Marketing Administrative Assistant

December 7, 2019 11:26 pm || Published by

CAI is a 100% employee-owned company established in 1996, that has grown year over year to almost 500 people worldwide. We provide commissioning, qualification, validation, start-up, project management and other consulting services to FDA regulated and other mission critical industries. CAI is seeking an energetic and self-motivated Marketing Administrative Assistant to support the Sales & Marketing team. This role will be primarily responsible for providing marketing support for tradeshows, department shipping and mailing needs, content proofreading, ordering promotional items and printed materials, and more. This position reports to the Director of Sales and Marketing. A qualified candidate needs to have a strong work ethic, be capable of working remotely without continuous direct supervision, and meet project deadlines with high-quality results. This role requires the ability to provide exceptional customer service and an outgoing personality that adapts well to a variety of types of individuals within the organization. A successful candidate is expected to represent CAI in a professional manner. This is a full-time position with 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. Responsibilities: Administrative: Manage Marketing email inbox to support incoming requests. Manage and maintain company collateral such as Statement of Qualifications (SOQ), project profiles, employee/project photographs, etc. Resume creation and maintenance. Assist in proposal support to meet deadlines set by proposal team. Manage calendar of events, holiday card ordering and distribution, ordering of branded clothing, and business cards. Serve as system administrator back-up for internal CRM tool. Marketing Events: Support pre-show/conference planning, coordination, and post-show/conference follow up. Responsible for marketing material management, shipping and receiving of event items, promotional item ordering as directed, and inventory management. Data Management and Reporting: Maintain accuracy of Customer Relationship Management (CRM) contacts and company information.   Qualifications/Skills: Strong written and verbal communication skills High level of organization and attention to detail Comfort with multi-tasking in a deadline-driven environment Understanding of basic business and marketing concepts Excellent time management skills Outgoing personality with strong interpersonal and social abilities Familiarity with social media, social networking, email marketing and search engines Demonstrated problem solving and critical thinking skills Strong writing and copy-editing abilities   Education/Experience Requirements: High School diploma or GED certificate 0-3 years of experience in marketing or equivalent education Associate or bachelor’s degree in marketing, business or a related field a plus Proficiency with Microsoft Office Experience with Adobe Creative Cloud (Illustrator, InDesign, Photoshop) a plus Experience with CRM (HubSpot preferred) a plus   Working Conditions: Extensive computer and phone usage Local travel is expected Must be able to lift boxes and containers up to 50lbs Able to travel domestically  Able to work (paid) overtime  Able to work in the US without sponsorship now or any time or in the future. 

Computer System Validation Engineer

December 7, 2019 11:26 pm || Published by

CAI is a 100% employee-owned company established in 1996, that has grown year over year to almost 500 people worldwide. We provide commissioning, qualification, validation, start-up, project management and other consulting services to FDA regulated and other mission critical industries.   CAI is seeking motivated Computer System Validation (CSV) Engineers to support biotech and pharmaceutical projects across the country. These are full-time opportunities with 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.   As consultants to the entire industry, our employee owners are driven by the challenge and constant diversity of assignments, while having the stability of a company that has never had a lay off. On any given day we could be responsible for a myriad of things involved in starting a facility, equipment or process up including protocol writing and execution, FAT's SAT's, walk downs and development of summary reports at the client site.    To get to those diverse projects our people can experience heavy travel. Although some people rarely travel, it is the exception to the rule. It’s not unusual for our employee owners to travel locally M-F to client sites. If the distance is greater, or spans more time zones, we sometimes travel to the site for 10 days then come back for 4. We don’t want to spend our free time in airports or doing laundry to pack again, and we don’t expect our employees to.   The Computer Systems Validation (CSV) Engineer will develop and execute protocols and test scripts. This person is responsible for writing GxP computer validation and 21 CFR Part 11 related documentation such as assessments, plans, URS, FRS, RTM, and summary reports.   Requirements include:  BS in a Computer Science or Engineering field or equivalent experience 1-4 years’ experience with Computer systems validation in the USA 2 years’ experience working in a GMP environment Experience with GAMP is highly desired Experience in biotech and pharma is preferred over medical device Experience with MES, Delta V, PI is a plus. We use all majors systems as we serve a multitude of clients. Rockwell, GE, Emerson, ABB, Werum, Siemens, Honeywell and their associated platforms, PAS-X, Syncade, FactoryTalk, PharmaSuite, FactoryLogix, PLM, Simatic, iFix, Wonderware, etc. 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. 

Pharmaceutical Project Manager

December 7, 2019 9:19 pm || Published by

CAI is a 100% employee-owned company established in 1996, that has grown year over year to almost 500 people worldwide. We provide commissioning, qualification, validation, start-up, project management and other consulting services to FDA regulated and other mission critical industries. CAI is seeking motivated Pharmaceutical Project Manager to support biotech and pharmaceutical projects across the country. These are full-time opportunities with 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.   As consultants to the entire industry, our employee owners are driven by the challenge and constant diversity of assignments, while having the stability of a company that has never had a lay off. On any given day we could be responsible for a myriad of things involved in starting a facility, equipment or process up including protocol writing and execution, FAT's SAT's, walk downs and development of summary reports at the client site.    To get to those diverse projects our people can experience heavy travel. Although some people rarely travel, it is the exception to the rule. It’s not unusual for our employee owners to travel locally M-F to client sites. If the distance is greater, or spans more time zones, we sometimes travel to the site for 10 days then come back for 4. We don’t want to spend our free time in airports or doing laundry to pack again, and we don’t expect our employees to.   The Project Manager work with project teams at client sites to inspect, test, and troubleshoot bio-pharma manufacturing, packaging, and utility systems and equipment.  This person is responsible for identifying and coordinating activities for commissioning and qualification and creating engineering and qualification protocols and reports.  They will also manage the resources (people and budget) for same.  The Project Manager will interact with client (Bio-pharma companies) personnel and the Regional Manager.  The Project Manager will execute the work as well as oversee it.    Requirements Include: BS in a science or engineering field or equivalent experience 10+ 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 oral and written communication skills in English  Able to travel domestically and internationally if required  Able to work (paid) overtime  Able to work in the US without sponsorship now or any time or in the future. 

Commissioning and Qualification Engineer

December 7, 2019 9:19 pm || Published by

CAI is a 100% employee-owned company established in 1996, that has grown year over year to almost 500 people worldwide. We provide commissioning, qualification, validation, start-up, project management and other consulting services to FDA regulated and other mission critical industries.   CAI is seeking motivated CQV Engineers to support biotech and pharmaceutical projects across the country. These are full-time opportunities with 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.   As consultants to the entire industry, our employee owners are driven by the challenge and constant diversity of assignments, while having the stability of a company that has never had a lay off. On any given day we could be responsible for a myriad of things involved in starting a facility, equipment or process up including protocol writing and execution, FAT's SAT's, walk downs and development of summary reports at the client site.    To get to those diverse projects our people can experience heavy travel. Although some people rarely travel, it is the exception to the rule. It’s not unusual for our employee owners to travel locally M-F to client sites. If the distance is greater, or spans more time zones, we sometimes travel to the site for 10 days then come back for 4. We don’t want to spend our free time in airports or doing laundry to pack again, and we don’t expect our employees to.   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:  BS in a science or engineering field or equivalent years of experience 3 years' experience in commissioning and qualification 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 Excellent oral and written English is required Able to travel domestically and internationally if required  Able to work (paid) overtime  Able to work in the US without sponsorship now or any time or in the future

Computer Systems Validation Specialists (Puerto Rico)

December 7, 2019 9:19 pm || Published by

CAI is seeking motivated CSV Specialists to support biotech and pharmaceutical projects in Puerto Rico. These individuals need to reside on the Island or relocate at their own expense for the duration of the contract. The duration begins July 2019 and continues until October 2019. CAI is a 100% employee-owned company providing CQV, start-up, project management and consulting services to FDA regulated and mission critical industries.  CAI was established in 1996 and has steadily grown to be an industry leader with 500 employees worldwide. The Computer Systems Validation (CSV) Specialist will develop and execute protocols and test scripts. This person is responsible for writing GxP computer validation and 21 CFR Part 11 related documentation such as assessments, plans, URS, FRS, RTM, and summary reports.   Requirements include:  BS or higher in Computer Science/Information Systems & Technology/Engineering or related discipline. Knowledge on computerized system with data collection software (database). Knowledge with network communications protocol (i.e. TCP/IP) Strong knowledge of cGMP, FDA, 21 CFR Part 11 and Data Integrity Regulations. Acquainted with GAMP5 methodology for validations. At least three (3) years of experience working with PLC’s, Industrial Computers and SCADA systems. Background in pharmaceutical products manufacturing environment. Good skills writing validation/commissioning, and technical documentation in English and using MS Office applications. Bilingual in English/Spanish Able to travel domestically and internationally as required  Able to work in the US without sponsorship now or any time in the future. 

Computer System Validation Engineer

December 7, 2019 9:19 pm || Published by

CAI is a 100% employee-owned company established in 1996, that has grown year over year to almost 500 people worldwide. We provide commissioning, qualification, validation, start-up, project management and other consulting services to FDA regulated and other mission critical industries.   CAI are seeking motivated Computer System Validation (CSV) Engineers to support biotech and pharmaceutical projects across the country. These are full-time opportunities with 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.   As consultants to the entire industry, our employee owners are driven by the challenge and constant diversity of assignments, while having the stability of a company that has never had a lay off. On any given day we could be responsible for a myriad of things involved in starting a facility, equipment or process up including protocol writing and execution, FAT's SAT's, walk downs and development of summary reports at the client site.    To get to those diverse projects our people can experience heavy travel. Although some people rarely travel, it is the exception to the rule. It’s not unusual for our employee owners to travel locally M-F to client sites. If the distance is greater, or spans more time zones, we sometimes travel to the site for 10 days then come back for 4. We don’t want to spend our free time in airports or doing laundry to pack again, and we don’t expect our employees to.   The Computer Systems Validation (CSV) Engineer will develop and execute protocols and test scripts. This person is responsible for writing GxP computer validation and 21 CFR Part 11 related documentation such as assessments, plans, URS, FRS, RTM, and summary reports.   Requirements include:  BS in a Computer Science or Engineering field or equivalent experience 4 years’ experience with Computer systems validation in the USA 2 years’ experience working in a GMP environment Experience with GAMP is highly desired Experience in biotech and pharma is preferred over medical device Experience with MES, Delta V, PI is a plus. We use all major systems as we serve a multitude of clients. Rockwell, GE, Emerson, ABB, Werum, Siemens, Honeywell and their associated platforms, PAS-X, Syncade, FactoryTalk, PharmaSuite, FactoryLogix, PLM, Simatic, iFix, Wonderware, etc. Lab experience or IT experience with regards to Lab Data Management Systems is preferred but not required 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. 

Bio Manufacturing Process & Validation Engineers

December 7, 2019 9:19 pm || Published by

CAI is a 100% employee-owned company established in 1996, that has grown year over year to almost 500 people worldwide. We provide commissioning, qualification, validation, start-up, project management, design and other consulting services to FDA regulated and mission critical industries.   CAI is seeking motivated biomanufacturing process engineers and biomanufacturing validation engineers to support biotech and pharmaceutical projects across the country. These are full-time opportunities with 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.   As consultants to numerous types of industry, our employee owners are driven by the challenge and constant diversity of assignments, while having the stability of a consistently growing company.              Travel is required to achieve full success for the agents and the clients we serve.  Most travel occurs within the US, but international travel can be also be requested as interested.  Please check CAI out on Glassdoor to get a better perspective on our culture and travel. We are extremely proud that our employee owners have given us so many 5 star ratings.   Position Requirements:  BS or MS in a relevant engineering or science field, or equivalent experience Excellent oral and written communication skills in English Team-oriented Customer-service focused Able to travel domestically and internationally if required Able to work (paid) overtime as needed Able to work in the US without sponsorship now or any time in the future   Process Engineering Experience: Three (3) or more years of experience in designing, operating, installing, troubleshooting, commissioning and/or qualifying of: Bioreactors, media and harvest vessels, filtration systems, chromatography systems, clean utilities Process facility design and construction: clean rooms, labs, environmental control systems for classified spaces, cold chain storage, waste processing Single use biomanufacturing systems Continuous Process Verification (CPV) (using Minitab or other statistical software) Process performance qualification (PPQ) Deviation and CAPA investigations Experience with biomanufacturing processes: Cell culture, expansion, harvest, purification, formulation, fill and finish Blood plasma fractionation and component purification Cell and gene therapy     Other Desired Experience: Commissioning and Qualification Developing Validation / Verification Master Plans Performing formal risk assessments / FMEA Identifying Critical Attributes and Critical Process Parameters Developing User Requirements Writing qualification protocols, commissioning plans/test scripts, and summary reports Developing trace-ability matrices Project Management Project planning and estimating Schedule development and execution Issue tracking and resolution Establishing metrics and leading team to achieve performance goals Facilitating meetings

Computer System Validation Engineer

December 7, 2019 9:19 pm || Published by

CAI is a 100% employee-owned company established in 1996, that has grown year over year to almost 500 people worldwide. We provide commissioning, qualification, validation, start-up, project management and other consulting services to FDA regulated and other mission critical industries.   CAI are seeking motivated Computer System Validation (CSV) Engineers to support biotech and pharmaceutical projects across the country. These are full-time opportunities with 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.   As consultants to the entire industry, our employee owners are driven by the challenge and constant diversity of assignments, while having the stability of a company that has never had a lay off. On any given day we could be responsible for a myriad of things involved in starting a facility, equipment or process up including protocol writing and execution, FAT's SAT's, walk downs and development of summary reports at the client site.    To get to those diverse projects our people can experience heavy travel. Although some people rarely travel, it is the exception to the rule. It’s not unusual for our employee owners to travel locally M-F to client sites. If the distance is greater, or spans more time zones, we sometimes travel to the site for 10 days then come back for 4. We don’t want to spend our free time in airports or doing laundry to pack again, and we don’t expect our employees to.   The Computer Systems Validation (CSV) Engineer will develop and execute protocols and test scripts. This person is responsible for writing GxP computer validation and 21 CFR Part 11 related documentation such as assessments, plans, URS, FRS, RTM, and summary reports.   Requirements include:  BS in a Computer Science or Engineering field or equivalent experience 3 years’ experience with Computer systems validation in the USA 2 years’ experience working in a GMP environment Experience with GAMP is highly desired Experience in biotech and pharma is preferred over medical device Experience with MES, Delta V, PI is a plus. We use all major systems as we serve a multitude of clients. Rockwell, GE, Emerson, ABB, Werum, Siemens, Honeywell and their associated platforms, PAS-X, Syncade, FactoryTalk, PharmaSuite, FactoryLogix, PLM, Simatic, iFix, Wonderware, etc. 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. 

Quality Assurance (QA) Validation Associate

December 7, 2019 9:19 pm || Published by

CAI is a 100% employee-owned company established in 1996, that has grown year over year to almost 500 people worldwide. We provide commissioning, qualification, validation, start-up, project management and other consulting services to FDA regulated and other mission critical industries.   CAI are seeking motivated Quality Assurance (QA) Validation Associate to support biotech and pharmaceutical projects across the country. These are full-time opportunities with 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.   As consultants to the entire industry, our employee owners are driven by the challenge and constant diversity of assignments, while having the stability of a company that has never had a lay off. On any given day we could be responsible for a myriad of things involved in starting a facility, equipment or process up including protocol writing and execution, FAT's SAT's, walk downs and development of summary reports at the client site.    To get to those diverse projects our people can experience heavy travel. Although some people rarely travel, it is the exception to the rule. It’s not unusual for our employee owners to travel locally M-F to client sites. If the distance is greater, or spans more time zones, we sometimes travel to the site for 10 days then come back for 4. We don’t want to spend our free time in airports or doing laundry to pack again, and we don’t expect our employees to.   The QA Validation Associate at CAI will provide Quality and Compliance guidance to domestic and international clients. This person will have responsibilities encompassing Pharmaceutical Quality Systems, Quality Risk Management, Inspection readiness and GMP Compliance.   Requirements include: BS in a science or equivalent discipline Proven track record in Quality and Compliance. Professional Quality Assurance Accreditation desirable Demonstrated Continual Professional Development 3-5 years' experience within GMP regulated facilities Experience with Aseptic manufacture desirable Experience with Packaging processes desirable Pharmaceutical Compounding experience desirable Deviation and CAPA program experience Remediation project management a plus Experience with project management is a plus Experience delivering efficient QA compliance solutions overseeing and reviewing the SDLC/CSV/Qualification activities. Oversight of execution for Validations and Qualifications. QA oversight of testing activities. Reviews completed qualification and validation protocols, summary reports and associated data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria. Analyses the results of testing and determines the acceptability of results against pre-determined criteria. Excellent oral and written communication skills in English  Able to travel domestically and internationally if required  Able to work (paid) overtime  Able to work in the US without sponsorship now or any time in the future. 

Aseptic Process & Validation Engineers

December 7, 2019 9:19 pm || Published by

CAI is a 100% employee-owned company established in 1996, that has grown year over year to almost 500 people worldwide. We provide commissioning, qualification, validation, start-up, project management, design and other consulting services to FDA regulated and mission critical industries.   CAI is seeking motivated: ·        Aseptic Process Engineers and Aseptic Validation Engineers   to support biotech and pharmaceutical projects across the country. These are full-time opportunities with 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.   As consultants to numerous types of industry, our employee owners are driven by the challenge and constant diversity of assignments, while having the stability of a consistently growing company.              Travel is required to achieve full success for the agents and the clients we serve.  Most travel occurs within the US, but international travel can be also be requested as interested.  Please check CAI out on Glassdoor to get a better perspective on our culture and travel. We are extremely proud that our employee owners have given us so many 5 star ratings.   Position Requirements:  ·        BS or MS in a relevant engineering or science field, or equivalent experience ·        Excellent oral and written communication skills in English ·        Team-oriented ·        Customer-service focused ·        Able to travel domestically and internationally if required ·        Able to work (paid) overtime as needed ·        Able to work in the US without sponsorship now or any time in the future     Aseptic Process Engineering Experience:   ·        Three (3) or more years of experience in designing, operating, installing, troubleshooting, commissioning and/or qualifying of: o   cGMP manufacturing process activities within isolators or biosafety cabinets (e.g. Cell and Gene Therapy) o   Sterile Operations - Vial/prefilled syringe/cartridge filling lines o   Lyophilization/freeze drying o   Automated visual inspection systems o   Automated formulation systems o   Autoclaves o   CIP/SIP   Other Desired Experience:   ·        Commissioning and Qualification o   Developing Validation / Verification Master Plans o   Performing formal risk assessments / FMEA o   Identifying Critical Attributes and Critical Process Parameters o   Developing User Requirements o   Writing qualification protocols, commissioning plans/test scripts, and summary reports o   Developing tracability matrices   ·        Project Management o   Project planning and estimating o   Schedule development and execution o   Issue tracking and resolution o   Establishing metrics and leading team to achieve performance goals o   Facilitating meetings