About CAI:
CAI is a 100% employee-owned company established in 1996, that has grown year over year to nearly 850 people worldwide. We provide commissioning, qualification, validation, start-up, project management and consulting services related to operational readiness to FDA regulated and other mission critical industries.
Meeting a Higher Standard:
Our approach is simple; we put the client’s interests first, we do not stop until it is right, and we will do whatever it takes to get there.
As owners of CAI, we are committed to living our Foundational Principles, both professionally and personally:
· We act with integrity,
· We serve each other,
· We serve society,
· We work for our future.
With employee ownership, one person’s success is everyone’s success; we work diligently to accomplish team goals. We place Team Before Self, demonstrate Respect for Others, and possess a can-do attitude. That is how we have grown exponentially.
CAI agents will be exposed to cutting edge technologies in the advanced medicine space. You will have an opportunity to work with recognized subject matter experts allowing YOU to be a key player in bringing lifesaving therapies to market. As part of our company culture, we invest in YOUR future, and commit to hands on certifications as well as professional training. Our collaborative culture ensures that our customers benefit from exemplary work across our entire range of professional services.
Requirements include:
We are now seeking a Senior CQV Project Manager to join our growing operations in Europe. The role of a Senior CQV PM in CAI is to:
· Provide cGMP leadership and guidance for the integration and delivery of CQV services for our Life Sciences clients.
· Managing mid-sized to large projects related to process equipment and clean utilities including start-up and commissioning
· Lead design review, site acceptance and installation of equipment
· Write, Review and Approve CQV documents following established 21 CFR standards, both internally and externally. Document requests could include: Standard Operating Procedures, Impact Assessments, Risk Assessments, Specifications (URS/FRS/DDS), FATs, SATs, IOQ/PQs, Validation Protocols and Commissioning Test Plans
· Support onsite and offsite activities, such as: FATs, SATs, Executions and System Walkdowns
· Management of any aspect of C & Q, verification as requested i.e., Change Controls, Management of Contractors and Vendors, document control, punch list management.
· Allocate project resources for efficient execution of project deliverables.
· Deliver the C&Q activities as required to meet the schedule
· Track progress of C&Q activities as required.
· Coordinate support during C&Q execution
Position Requirements:
· BS or MS in a relevant science or engineering field, or equivalent
· 8 + years of Commissioning, Qualification, Validation and Compliance experience in the Life Sciences or Regulated Industries; Sound technical knowledge of EU and global regulatory requirements. Proficient in cGMP standards.
· Experience in collaborating and managing Commissioning, Qualification and Validation deliverables for one or Multiple Projects
· Skilled at planning and tracking project activities and schedules
· Excellent interpersonal skills to form strong relationships with internal and external clients
· Excellent oral and written communication skills
· Excellent problem-solving skills
· Customer-service focused.
· Proficient in life science manufacturing processes in areas such as biotech, aseptic fill/finish, OSD, Gene Therapy or equivalent experience.
· Able to travel domestically and internationally if required.
We are seeking CQV Engineers with 2-4 years' experience and we can assist with relocation costs.
Position Description:
The Commissioning, Qualification and Validation (CQV) Engineer will develop and execute protocols and test scripts, identify gaps, and consult on and direct plans for resolution. This person is responsible for writing commissioning and qualification documentation such as User Requirements, Design Qualification, commissioning and qualification test cases and protocols, and summary reports.
Requirements include:
Position Requirements:
BS or MS in a relevant science or engineering field, or equivalent
2-4 years' experience with commissioning, qualification and/or validation preferred
Experience with manufacturing process equipment—specifically filling, packaging and/or inspection equipment.
Excellent skill in leading teams to perform complex tasks under pressure
Excellent problem-solving skills
Customer-service focused
Other Requirements:
Excellent oral and written communication skills in English/Fluent in English
Able to travel domestically and internationally as required
Able to work (paid) overtime
Able to work in the US without sponsorship now or any time in the future.
About CAI
CAI is a 100% employee-owned company established in 1996 that has grown to more than 800 people worldwide. We provide commissioning, qualification, validation, start-up, project management and other consulting services associated with operational readiness to FDA regulated and other mission-critical industries.
Meeting a Higher Standard
Our approach is simple; we put the client’s interests first, we do not stop until it is right, and we will do whatever it takes to get there.
As owners of CAI, we are committed to living our Foundational Principles, both professionally and personally:
We act with integrity.
We serve each other.
We serve society.
We work for our future.
With employee ownership, one person’s success is everyone’s success; we work diligently to accomplish team goals. We place Team Before Self, demonstrate Respect for Others, and possess a Can-Do Attitude (our core values). That is how we have grown exponentially.
Benefits
Our full-time positions offer competitive compensation and benefits which include: up to 15% retirement contribution, 24 days PTO and 5 sick days per year, health insurance at extremely low cost to employee, financial support for both internal and external professional education as well as 70% long term disability paid for by the company.
#LI-MV1
We are seeking CQV Engineers with 4-8 years' experience and we can assist with relocation costs.
Position Description:
The CQV Engineer develops the documentation to support Commissioning, Qualifications, and Validation. These people are responsible for protocol writing and execution, field verification, and development of summary reports at the client site. Other responsibilities include planning/coordinating work and directing small teams in document development and/or execution.
Requirements include:
Position Requirements:
BS in a science or engineering field or equivalent years of experience
4-8 years' experience in commissioning and/or qualification activities in a regulated industry
Excellent technical problem-solving and troubleshooting skills, with solid knowledge of typical project technical issues
High attention to detail
Ability to multi-task and take initiative to accomplish assigned tasks accurately by established deadlines
Ability to work independently, while quickly building and nurturing a project team
Expertise in Microsoft Word and Excel
Familiarity with ISPE Baseline Guide 5 (Second Edition) a plus
Experience in planning / directing C&Q activities a plus
Must have experience in 1 or more of the following: facilities and equipment startup, walk downs & troubleshooting, utilities (WFI, RO, HVAC) upstream, downstream, purification, recovery, building automation or other pharmaceutical manufacturing processes
Other Requirements:
Excellent oral and written communication skills in English/Fluent in English
Able to travel domestically and internationally as required
Able to work (paid) overtime
Able to work in the US without sponsorship now or any time in the future.
About CAI
CAI is a 100% employee-owned company established in 1996, that has grown year over year to more than 800 people worldwide. We provide commissioning, qualification, validation, start-up, project management and consulting services related to operational readiness to FDA regulated and other mission critical industries.
Meeting a Higher Standard
Our approach is simple; we put the client’s interests first, we do not stop until it is right, and we will do whatever it takes to get there.
As owners of CAI, we are committed to living our Foundational Principles, both professionally and personally:
We act with integrity
We serve each other
We serve society
We work for our future
With employee ownership, one person’s success is everyone’s success; we work diligently to accomplish team goals. We place Team Before Self, demonstrate Respect for Others, and possess a can-do attitude. That is how we have grown exponentially.
Benefits
Our full-time positions offer competitive compensation and benefits which include: up to 15% retirement contribution, 24 days PTO and 5 sick days per year, health insurance at extremely low cost to employee, financial support for both internal and external professional education as well as 70% long term disability paid for by the company.
#LI-MV1
Position Description:
The Validation Engineer develops documentation for the Commissioning, Qualification, and Validation of pharmaceutical facilities, utilities, and equipment. These people are responsible for protocol writing and execution (field verification), and development of summary reports at client sites.
Requirements include:
Position Requirements:
BS or equivalent years of hands on experience
2 - 4 years experience performing commissioning and / or qualification activities in a regulated industry
Excellent technical problem-solving and troubleshooting skills
High attention to detail
Ability to multi-task and take initiative to accomplish assigned tasks accurately by established deadlines
Ability to work independently, while supporting other team members
Expertise in Microsoft Word and Excel
Familiarity with ISPE Baseline Guide 5 (Second Edition) a plus.
Other Requirements:
Excellent oral and written communication skills in English/Fluent in English
Able to travel domestically and internationally as required
Able to work (paid) overtime
Able to work in the US without sponsorship now or any time in the future.
About CAI
CAI is a 100% employee-owned company established in 1996 that has grown to more than 800 people worldwide. We provide commissioning, qualification, validation, start-up, project management and other consulting services associated with operational readiness to FDA regulated and other mission-critical industries.
Meeting a Higher Standard
Our approach is simple; we put the client’s interests first, we do not stop until it is right, and we will do whatever it takes to get there.
As owners of CAI, we are committed to living our Foundational Principles, both professionally and personally:
We act with integrity.
We serve each other.
We serve society.
We work for our future.
With employee ownership, one person’s success is everyone’s success; we work diligently to accomplish team goals. We place Team Before Self, demonstrate Respect for Others, and possess a Can-Do Attitude (our core values). That is how we have grown exponentially.
Benefits
Our full-time positions offer competitive compensation and benefits which include: up to 15% retirement contribution, 24 days PTO and 5 sick days per year, health insurance at extremely low cost to employee, financial support for both internal and external professional education as well as 70% long term disability paid for by the company.
#LI-MV1
We are seeking CQV Engineers with 4-12 years' experience and we can assist with relocation costs.
Position Description:
The CQV Engineer develops the documentation to support Commissioning, Qualifications, and Validation. These people are responsible for protocol writing and execution, field verification, and development of summary reports at the client site. Other responsibilities include planning/coordinating work and directing small teams in document development and/or execution.
Requirements include:
Position Requirements:
BS in a science or engineering field or equivalent years of experience
4-12 years' experience in commissioning and/or qualification activities in a regulated industry
Excellent technical problem-solving and troubleshooting skills, with solid knowledge of typical project technical issues
High attention to detail
Ability to multi-task and take initiative to accomplish assigned tasks accurately by established deadlines
Ability to work independently, while quickly building and nurturing a project team
Expertise in Microsoft Word and Excel
Familiarity with ISPE Baseline Guide 5 (Second Edition) a plus
Experience in planning / directing C&Q activities a plus
Must have experience in 1 or more of the following: facilities and equipment startup, walk downs & troubleshooting, utilities (WFI, RO, HVAC) upstream, downstream, purification, recovery, building automation or other pharmaceutical manufacturing processes
Other Requirements:
Excellent oral and written communication skills in English/Fluent in English
Able to travel domestically and internationally as required
Able to work (paid) overtime
Able to work in the US without sponsorship now or any time in the future.
About CAI
CAI is a 100% employee-owned company established in 1996, that has grown year over year to more than 800 people worldwide. We provide commissioning, qualification, validation, start-up, project management and consulting services related to operational readiness to FDA regulated and other mission critical industries.
Meeting a Higher Standard
Our approach is simple; we put the client’s interests first, we do not stop until it is right, and we will do whatever it takes to get there.
As owners of CAI, we are committed to living our Foundational Principles, both professionally and personally:
We act with integrity
We serve each other
We serve society
We work for our future
With employee ownership, one person’s success is everyone’s success; we work diligently to accomplish team goals. We place Team Before Self, demonstrate Respect for Others, and possess a can-do attitude. That is how we have grown exponentially.
Benefits
Our full-time positions offer competitive compensation and benefits which include: up to 15% retirement contribution, 24 days PTO and 5 sick days per year, health insurance at extremely low cost to employee, financial support for both internal and external professional education as well as 70% long term disability paid for by the company.
#LI-MV1
We are seeking CQV Engineers with 4-8 years' experience and we can assist with relocation costs.
Position Description:
The CQV Engineer develops the documentation to support Commissioning, Qualifications, and Validation. These people are responsible for protocol writing and execution, field verification, and development of summary reports at the client site.
Requirements include:
Position Requirements:
BS in a science or engineering field or equivalent years of experience
4-8 years' experience in commissioning and/or qualification activities in a regulated industry
Excellent technical problem-solving and troubleshooting skills, with solid knowledge of typical project technical issues
High attention to detail
Ability to multi-task and take initiative to accomplish assigned tasks accurately by established deadlines
Ability to work independently, while quickly building and nurturing a project team
Expertise in Microsoft Word and Excel
Familiarity with ISPE Baseline Guide 5 (Second Edition) a plus
Experience in planning / directing C&Q activities a plus
Must have experience in 1 or more of the following: facilities and equipment startup, walk downs & troubleshooting, utilities (WFI, RO, HVAC) upstream, downstream, purification, recovery, building automation or other pharmaceutical manufacturing processes
Other Requirements:
Excellent oral and written communication skills in English/Fluent in English
Able to travel domestically and internationally as required
Able to work (paid) overtime
Able to work in the US without sponsorship now or any time in the future.
About CAI
CAI is a 100% employee-owned company established in 1996, that has grown year over year to more than 800 people worldwide. We provide commissioning, qualification, validation, start-up, project management and consulting services related to operational readiness to FDA regulated and other mission critical industries.
Meeting a Higher Standard
Our approach is simple; we put the client’s interests first, we do not stop until it is right, and we will do whatever it takes to get there.
As owners of CAI, we are committed to living our Foundational Principles, both professionally and personally:
We act with integrity
We serve each other
We serve society
We work for our future
With employee ownership, one person’s success is everyone’s success; we work diligently to accomplish team goals. We place Team Before Self, demonstrate Respect for Others, and possess a can-do attitude. That is how we have grown exponentially.
Benefits
Our full-time positions offer competitive compensation and benefits which include: up to 15% retirement contribution, 24 days PTO and 5 sick days per year, health insurance at extremely low cost to employee, financial support for both internal and external professional education as well as 70% long term disability paid for by the company.
#LI-MV1
We are seeking CQV Engineers with 4-8 years' experience and we can assist with relocation costs.
Position Description:
The CQV Engineer develops the documentation to support Commissioning, Qualifications, and Validation. These people are responsible for protocol writing and execution, field verification, and development of summary reports at the client site.
Requirements include:
Position Requirements:
BS in a science or engineering field or equivalent years of experience
4-8 years' experience in commissioning and/or qualification activities in a regulated industry
Excellent technical problem-solving and troubleshooting skills, with solid knowledge of typical project technical issues
High attention to detail
Ability to multi-task and take initiative to accomplish assigned tasks accurately by established deadlines
Ability to work independently, while quickly building and nurturing a project team
Expertise in Microsoft Word and Excel
Familiarity with ISPE Baseline Guide 5 (Second Edition) a plus
Experience in planning / directing C&Q activities a plus
Must have experience in 1 or more of the following: facilities and equipment startup, walk downs & troubleshooting, utilities (WFI, RO, HVAC) upstream, downstream, purification, recovery, building automation or other pharmaceutical manufacturing processes
Other Requirements:
Excellent oral and written communication skills in English/Fluent in English
Able to travel domestically and internationally as required
Able to work (paid) overtime
Able to work in the US without sponsorship now or any time in the future.
About CAI
CAI is a 100% employee-owned company established in 1996, that has grown year over year to more than 800 people worldwide. We provide commissioning, qualification, validation, start-up, project management and consulting services related to operational readiness to FDA regulated and other mission critical industries.
Meeting a Higher Standard
Our approach is simple; we put the client’s interests first, we do not stop until it is right, and we will do whatever it takes to get there.
As owners of CAI, we are committed to living our Foundational Principles, both professionally and personally:
We act with integrity
We serve each other
We serve society
We work for our future
With employee ownership, one person’s success is everyone’s success; we work diligently to accomplish team goals. We place Team Before Self, demonstrate Respect for Others, and possess a can-do attitude. That is how we have grown exponentially.
Benefits
Our full-time positions offer competitive compensation and benefits which include: up to 15% retirement contribution, 24 days PTO and 5 sick days per year, health insurance at extremely low cost to employee, financial support for both internal and external professional education as well as 70% long term disability paid for by the company.
#LI-MV1
Position Description:
Our project managers are technical leads first, with a strong background in CQV strategy, development, and field execution. We look for culture fit above all – our people are our most important asset, and great people make great teams! Our ideal project manager will have experience managing projects of $1m or more, and have managed teams of at least 6-8 engineers and consultants on defined scopes of work.
A successful CAI PM will need to show direct responsibility for scope/schedule/budget for project experience. We love experienced generalists, but if you’re a CQV SME in facilities, clean utilities, upstream and downstream biotech equipment, single use disposable, or aseptic fill finish manufacturing, we’d like to talk to you! A PMP is great, but you’ll need the experience if you want to run with a CAI team. On any given day, you might be leading a budget review meeting, leading a daily huddle with your team, reviewing a summary report, writing a protocol, or supporting your team executing in the field. CAI PMs are active, multifaceted roles - desktop PMs need not apply! The CAI project manager typically reports to either a client manager or an area manager.
Requirements include:
Requirements Include:
BS in a science or engineering field or equivalent experience
8-12 years’ Experience commissioning and qualifying bio-pharma systems equipment and systems
Experience with risk assessments, qualification protocols, commissioning plans/test scripts and summary reports is desired Experience with CIP/SIP is desired
Excellent skill in leading teams to perform complex tasks under pressure
Excellent problem-solving skills
Proficient and experienced with various Project Management software tools
Customer-service focused
Three (3) or more years serving as a program or project manager for life science projects with budgets of $1MM+. Demonstrated success in leading your team to achieve defined goals. Similar experience in industries other than life sciences will be considered.
Other Requirements:
Excellent oral and written communication skills in English
Able to travel domestically and internationally as required
Able to work (paid) overtime
Able to work in the US without sponsorship now or any time in the future.
About CAI
CAI is a 100% employee-owned company established in 1996 that has grown to more than 800 people worldwide. We provide commissioning, qualification, validation, start-up, project management and other consulting services associated with operational readiness to FDA regulated and other mission-critical industries.
Meeting a Higher Standard
Our approach is simple; we put the client’s interests first, we do not stop until it is right, and we will do whatever it takes to get there.
As owners of CAI, we are committed to living our Foundational Principles, both professionally and personally:
We act with integrity.
We serve each other.
We serve society.
We work for our future.
With employee ownership, one person’s success is everyone’s success; we work diligently to accomplish team goals. We place Team Before Self, demonstrate Respect for Others, and possess a Can-Do Attitude (our core values). That is how we have grown exponentially.
Benefits
Our full-time positions offer competitive compensation and benefits which include: up to 15% retirement contribution, 24 days PTO and 5 sick days per year, health insurance at extremely low cost to employee, financial support for both internal and external professional education as well as 70% long term disability paid for by the company.
#LI-MV1
About CAI:
CAI was established in 1996, it has grown year over year to more than 850 people worldwide. We provide commissioning, qualification, validation, start-up, project management and consulting services related to operational readiness to FDA regulated and other mission critical industries.
Meeting a Higher Standard
Our approach is simple; we put the client’s interests first, we do not stop until it is right, and we will do whatever it takes to get there.
At CAI, we are committed to living our Foundational Principles, both professionally and personally:
• We act with integrity
• We serve each other
• We serve society
• We work for our future.
We strongly believe that one person’s success is everyone’s success; we work diligently to accomplish team goals. We place Team Before Self, demonstrate Respect for Others, and possess a can-do attitude. That is how we have grown exponentially.
Job Description:
Leads execution of instrument and method validations at customer sites
Participates in customer meetings.
Inoculates and reads microbiology validation samples.
Participates in the writing of protocols, reports, and specifications.
Trains customer on instrument usage and inoculation technique
Drives deliverables to completion with structured timelines.
Qualifications:
Degree in microbiology, biology, or science-related field
Understanding of good documentation practices and general quality laboratory function
Ability to work independently and manage multiple projects simultaneously.
Strong attention to detail, organizational skills and drive to be successful.
Experience with aseptic technique and biological safety cabinets
Other Requirements:
Proficient in spoken and written English and /or a native language such as Japanese is essential..
Able to travel domestically and internationally if required.
Benefits:
In return for your skills and knowledge, CAI offers a wide range of benefits including:
· Competitive Salary
· Continuing education (internal and external)
· Opportunities to work on cutting edge projects in a highly evolving field
#LI-KO1
This Mechanical Engineer performs mechanical systems testing in compliance with a project schedule. The mechanical test engineer should have a working knowledge of mechanical P&IDs, electrical one-line drawings and a general understanding of mechanical systems: Mechanical (HVAC) systems, air distribution (fans, ducting, VAVs), refrigeration systems, chilled water systems, hot water heating systems, steam heating systems and fire protection equipment. He/she will drive the functional performance test for each mechanical system assigned and is expected to be able to competently follow approved test scripts. Needs to be self-motivated and willing to actively engage contractors/vendors to set up testing to complete all required activities for project success
The witness, verification and validation of proper execution of commissioning tests is to be documented by the Mechanical Test Engineer. The quality of documentation is vital to success of program and the Mechanical Test Engineer is expected to have knowledge and ability to complete all document requirements.
CAI is a rapidly expanding professional services organization headquartered in the United States with offices in Singapore and China. We work in the pharmaceutical, biotechnology, medical device, nutritional and building commissioning industries including data centers to provide industry best practices to our clients. Check us out at www.cagents.com
Responsibilities
· Lead and steer all mechanical commissioning and testing activities for all contracted testing and commissioning work related to mechanical, cooling, HVAC, airflow, water, refrigerant/return piping and plumbing systems (and possibly structural and civil expertise) at the client`s site according to agreed Scope of Works
· Guide technical discussion and clarification with client acting as and advisor/coordinator for any technical, mechanical, cooling, HVAC, airflow, water, refrigerant/return piping and plumbing related topics and in some circumstances structural and civil engineering related topics
· Act as technical expert and advisory for the client, advising on feasibility, practicality and any cost, resource impact of solution, methods and work procedures at all stages of the commissioning process
· Fulfil the role of on-site technical lead and coordinate obtaining correct information from equipment vendors, client, contactors and site owners to make decision and lead
· Participate and contribute to meetings with the client, consultants, other contractors to provide expert technical opinion. Work with all commissioning stakeholders to sign-off and commit to a common and agreed commissioning deliverables scope and outline items
· Ensuring all relevant certification and required documentation have been provided by construction contractors, equipment/system vendors to be approved and used as reference for commissioning documentation development
· Review, check, analyze, and provide opinion on design documents such as BoD, OPR, mechanical, cooling, HVAC, ducting, piping and plumbing drawings, schematics, diagrams and installation drawings as well as approve documents meeting commissioning requirements of the client
· Support engineering and commissioning deliverables development, working together with team members
· Develop, create, review and achieve approval of test scripts, Inspection Test Plans (ITPs)
· Develop, create, review, achieve approval and initiate Factory Acceptance Tests (FAT) or Factory Witness Tests (FWT)according to the needs of the client
· Ensure delivery quality is consistent with testing and commissioning requirement from client and the tested outcome is consistent with the client`s desired specification and performance requirements
· Enforce and work to the client`s project timelines and supervise all mechanical, cooling, ducting, piping and flow/balancing commissioning activities according to the client`s commissioning schedule and timeline
· Steer and guide all stakeholders (general contractors, equipment suppliers, BEP contractors) to achieve commissioning outcomes to the prerequisites of the client BoD and OPR, periodically assessing and evaluating the conformance, progress and suitability of planned work in line with the agreed commissioning deliverables
· Supervising, monitoring all mechanical, cooling, airflow, piping and plumbing commissioning works ensuring the tests are effective for all associated Cx levels
· Facilitating effective handover of equipment, facilities and outcomes from commissioning, ensuring all required certification and associated records, testing/verification documentation have been checked and approved and signed-off from vendors, construction contractors as well as by the company for test performance confirmation
· Check that critical decisions, actions and planning regarding commissioning are shared, reviewed and developed together with the company's global expertise to ensure consistency with the company`s global approach and policy, standards
Critical Skills and Knowledge
· Bachelor degree or equivalent experience
· Knowledge of OSHA safety requirements.
· Good written and spoken communication skills.
· Ability to read and interpret electrical schematics and mechanical P&IDs.
· Knowledge of mission critical design concepts.
· Knowledge of various Building Automation/Monitoring Systems (BAS/BMS), Air Handlers, Humidifiers, Variable Refrigerant Flow, Computer Room Air Conditioners/Handlers (CRAC/CRAH), Evaporators, Adiabatic Coolers, Pressure/Temperature/Humidity sensors & Flowmeters.
· Knowledge of basic thermodynamics and heat transfer and fluid flow.
· Knowledge of the Test, Adjust and Balance (TAB) process.
· Knowledge of mechanical trend analysis.
· Strong experience with Word, Excel and PowerPoint.
業務内容：
機械エンジニアとしてプロジェクトスケジュールに従ってシステムテストを行います。
テストを行うに辺り、機械P&ID、電気一線図面、機械システム(機械(HVAC)システム、空気分配(ファン、ダクト、VAV)、冷凍システム、冷水システム、温水暖房システム、蒸気加熱システム、防火装置)の一般的な理解に関する実用的な知識を持っている必要があります。
割り当てられた各機械システムの機能性能テストを実行し、承認されたテストスクリプト通りに行うこと。
自発的に、請負業者/ベンダーに積極的に関与し、プロジェクトの成功に必要なテスト全て完了させて頂きます。
適切に試運転テストが実行される旨立会いをし、認証の為の検証を行い機械テストエンジニアとしてテスト内容をドキュメント化する。
ドキュメントの品質はプログラムの成功に不可欠であり、機械エンジニアとしてテストに係る全ての要件を文書化出来る知識と能力を要求します。
会社概要：
CAI社は、米国に本社を置き、シンガポールと中国にオフィスを構える急速に拡大しているプロフェッショナルサービス組織です。
製薬業界から、バイオテクノロジー、医療機器、栄養業界、データセンターを含む建築業界と、各試運転業務に携わっており、業界のベスト水準をお客様に提供しています。
是非www.cagents.com で弊社の業務内容を確認下さい。
業務詳細：
・スコープとして合意された作業範囲内、
客先現場での機械、冷却、HVAC、気流、水、冷媒/リターン配管および配管システム(場合によっては構造的および土木的専門知識)に関連する全ての契約試験を遂行する。また、試運転作業のための機械試運転と試験に準ずる活動もリードし実行する。
・クライアントとの技術的な議論を行い、
冷却、HVAC、気流、水、冷媒/リターン配管、配管関連トピックについてのどんな技術的、機械的内容、状況によっては構造および土木関連トピックでも、
専門アドバイザー/コーディネーターとして議論し内容の明確化に努めます。
・クライアントの技術専門家及びアドバイザリーとして行動し、
コミッショニングプロセスのあらゆる段階で、実現可能性、実用性、およびソリューションのリソースへの影響、方法、作業手順について助言を行う。
・現場ではテクニカルリーダーの役割を果たし、機器ベンダー、クライアント、請負業者、サイト所有者から正しい情報を取得して状況判断し、作業活動を調整リードする。
・クライアント、コンサルタント、その他の請負業者との会議に参加し専門家の技術的意見を提供する。
・コミッショニングのすべての利害関係者と協力し、合意されたコミッショニング成果範囲と概要項目を確認する。
・関連する認証全て、及び必要な文書全てが、建設請負業者、機器/システムベンダーから提供受け、承認され、試運転文書開発の参考として使用されていることを確認する。
・BoD、OPR、機械、冷却、HVAC、ダクト、配管および配管図面、回路図、図表、設置図面などの設計文書をレビュー、チェック、分析し、意見の提供し、クライアントの試運転要件を満たす文書である旨承認する。
・エンジニアリング自体と試運転の成果開発を其々サポートし、チームメンバーと協力する。
・テストスクリプトと検査テスト計画(ITP)を開発し、作成後にレビューを行い、承認を受ける。
・クライアントのニーズに応じて、工場受け入れテスト(FAT)または工場証人テスト(FWT)を開発し、作成し、レビュー行い、承認を達成してテストを遂行する。
・納品品質がクライアントからのテストおよび試運転要件と一致し、テスト結果がクライアントの希望する仕様および性能要件と一致している旨を確認。
・クライアントのプロジェクトタイムラインを守り、それに沿って作業行い、クライアントの試運転スケジュールとタイムラインに従って、すべての機械、冷却、ダクト、配管、フロー/バランシングの試運転活動を監督する。
・コミッショニング結果が、クライアントのBoDおよびOPRの前提条件を満たして達成される様すべての利害関係者(ゼネコン、機器サプライヤー、BEP請負業者)を導き、計画された作業の適合性、進捗状況、整合性を評価する。
・すべての機械、冷却、気流、配管、配管の試運転作業を監督、監視し、クライアントからの要求レベルに対してテストが効果的である旨確認する。
・試運転設備と試運転結果の効果的な引き渡しを促進し、
必要認証全て及び関連する記録、試験/検証文書が、ベンダー、建設請負業者から、また、テスト性能確認の為に会社から各々チェックを受け承認されているかを確認する。
・試運転に関する重要決定、計画が、会社のグローバルな専門知識とともに共有され、レビュー、開発されていることを確認し、会社のグローバルなアプローチとそのポリシー、基準との一貫性が確保されているかも確認する。
必要スキルと知識：
・学士号または同等の経験。
・OSHAの安全要件に関する知識。
・優れた筆記力およびコミュニケーション力。
・電気回路図と機械的なP&IDを読み取って解釈する能力。
・根幹の重要設計コンセプトの知識。
・様々なビルオートメーション/監視システム(BAS / BMS)、エアハンドラ、加湿器、可変冷媒流量、コンピュータルームエアコン/ハンドラ(CRAC / CRAH)、蒸発器、断熱クーラー、圧力/温度/湿度センサー&流量計の知識。
・基本的な熱力学と、熱伝達と流体フローについての知識。
・テスト、調整、バランス(TAB)プロセスの知識。
・機械トレンド分析の知識。
・強力なワード、エクセル、PowerPoint使用経験。
#LI-KO1
“The ultimate goal of providing a robust, safe method to transfer solutions in the Manufacturing Facility was achieved and CAI played a major role with this safety initiative.”
INDUSTRY RESOURCES
Download articles and resources from industry events and publications.
