Validation Engineer Staff 2

April 19, 2024 ||
 
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 2-4 years' experience in commissioning and/or qualification activities in a regulated industry Ideally, you'll already 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 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

Electrical Commissioning Engineer Lead, Data Center

April 19, 2024 ||
 
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. The role: The Electrical Commissioning Engineer Lead provides direction of all electrical aspects of assigned commissioning projects from initial engagement through turn over to the client. He/she will be expected to execute against the project schedule through the coordination of contractors and/or vendors to complete the desired electrical system testing while ensuring the safety of oneself and other project personnel.   Responsibilities:  ·       Lead and steer all electrical commissioning and testing activities for all contracted testing and commissioning work related to electrical systems at the client`s site according to agreed Scope of Works. ·       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, electrical 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 electrical commissioning activities according to the client`s commissioning schedule and timeline  ·       Manage the progress of work through task completion progress tracking and regular work completion status updates. Pro-actively and regularly update, provide feedback and communicate on work progress with internal teams, Project Manager and client team on work progress ·       Create and develop regular technical reports regarding commissioning project status ·       Using expert knowledge to identify and create an informed opinion, clearly and transparently communicate to the Project Manager, Client Manager on issues, opportunities, challenges or risks to project schedule and resourcing during any stage of work ·       Track potential changes during job progression and have competency in understanding identifying scope variation (potential scope and requirement changes) and how it affects commissioning schedule, budgeting and initially defined commissioning targets ·       Collaborate closely with Project Manager when quantifying any scope variation including any price, budget or resource change and to assist in developing mitigation or contingency plans.   Critical Skills and Knowledge  ·       Bachelor degree or equivalent experience ·       Knowledge of OSHA (or equivalent) 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 Electrical Distribution Switchgear, Substations, Uninterruptable Power Sources (UPS), Automatic Transfer Switches (ATS), Batteries, Emergency Diesel Generators & Load Banks.  ·       Knowledge of power quality analysis  Working Environment: Extensive travel (75%) Construction environment #LI-KO1

Validation Engineer Senior 2

April 19, 2024 ||
 
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 8-12 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 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

CQV Project Manager Senior 1

April 19, 2024 ||
 
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 4-8 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

Validation Engineer Senior 1

April 19, 2024 ||
 
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

Validation Engineer Staff 2

April 19, 2024 ||
 
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

CQV Project Manager

April 19, 2024 ||
 
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. 

CQV Utilities Engineer

April 19, 2024 ||
 
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 now have an immediate requirement for multiple C&Q roles within the Utilities suite team on one of our largest client sites.  The candidates should be self-motivated team players with the ability to own and deliver tasks against schedule-based project deliverables.  The ability to adapt to different project challenges is key.  The ideal applicant must have 5+ years’ experience in the Commissioning of Black and/or Clean Utility systems within GMP facilities.  A degree in Building Services, Mechanical Engineering or related discipline is preferable. This is a site-based role during the C&Q phase with opportunity to work remotely when the project allows. Requirements include:   ·        Review and approval of C&Q documents, ·        Review and approval of CTOP’s and VTOP’s, ·        Generation of C&Q documents through electronic validation systems (Kneat or similar), ·        Digital C&Q test execution, ·        Witnessing of vendor commissioning activities, ·        Ownership of Utility systems throughout C&Q phase, ·        Reporting daily on C&Q progress,   Position Requirements: ·        BS or MS in a relevant science or engineering field, or equivalent ·        5+ years in CQV Utilities experience within the life sciences industry ·        Excellent oral and written communication skills ·        Excellent problem-solving skills ·        Customer-service focused. ·        Able to travel domestically and internationally if required. 

CQV/Validation Engineer

April 19, 2024 ||
 
About CAI: CAI is a 100% employee-owned company established in 1996, that has grown year over year to nearly 700 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 CQV Engineer to join our growing operations in Ireland The role of a CQV Engineer in CAI is to:   ·        Conduct and lead Commissioning, Qualification, Validation team activities with a direct regard for Safety. ·        Managing the C&Q documentation and execution lifecycle from SLIA generation through to OQ completion. ·        Generating C&Q Procedures for projects.  ·        Approval of TOPs. ·        Facilitate scoping / planning of commissioning spares and consumables. ·        Deliver the C&Q activities as required to meet the schedule ·        Track progress of C&Q activities as required. ·        Preparation of Qualification Summary Reports (QSR), and management of Requirement Traceability Matrix (RTM) ·        Execution of Design reviews, shakedown, commissioning, FAT's, IQ, OQ, PQ activities. ·        Management of any aspect of C & Q, verification as requested i.e., Change Controls, Management of Contractors and Vendors, document control, punch list management. ·        Coordinate with project contractors and equipment vendors to execute required tests. ·        Allocate project resources for efficient execution of project deliverables. ·        Coordinate support during C&Q execution - Position Requirements: ·        BS or MS in a relevant science or engineering field, or equivalent ·        3+ years in CQV SME roles for life sciences – Clean Utilities/Filling experience preferable ·        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. 

QP – Qualified Person

April 19, 2024 ||
 
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 Qualified Person (QP) to join our growing operations in Ireland. The role of a QP in CAI is to:   ·        The Qualified Person is responsible for certifying medicinal products in accordance with requirements of product marketing authorisation, EU Directives, EU Annex 16 and Annex 13 where applicable for Investigational Medicinal Products. ·        Provide quality and compliance guidance on critical and major quality matters. ·        Provide quality direction and guidance for projects related to processes, product and compliance ·        Provide quality oversight of quality management system, procedures, release and compliance documents including CAPAs (Corrective and Preventive Action), Deviation Management, Change Controls and Quality Agreements. ·        Ensure all necessary manufacturing, packaging and associated documentation has been completed and endorsed by suitably authorized staff. ·        Ensure independence of the QP (Qualified Person) on decisions on quality related matters. ·        Provide support with investigations and resolution of discrepancies. ·        Provide audit support as required for client Health Authority Inspections, internal auditing program and supplier audits. ·        Support client in continuous improvement initiatives for GMP compliance. ·        Participate in cross functional teams to provide consultative support on quality related issues. ·        Maintain an up-to-date knowledge of pharmaceutical legislation and industry practice ·        Supporting Quality / Compliance / Regulatory (QCR) CAI business area lead (BAL) with the achievement of Objectives and Key Results (OKRs).   Position Requirements:   ·        Third level qualification in a science related discipline ·        Eligible and demonstrated ability to act as Qualified Person within EC/EEA. ·        Minimum 3 to 5 years QP experience ·        Must have excellent communication skills, including excellent written, interpersonal, collaboration, and negotiation skills, with a team-oriented approach. ·        Extensive demonstrated pharmaceutical quality experience. ·        Must have thorough knowledge of biopharmaceutical and/or pharmaceutical manufacturing, packaging, testing, and distribution processes and associated global regulatory GMP/GDP requirements. ·        Audit experience would be beneficial. ·        Must have strong task management skills with the ability to prioritise, schedule, and control under tight deadlines.