Navy Nuclear Trained Personnel for Data Center, Building Commissioning and Pharma CQV

July 12, 2020 1:40 pm || Published by

CAI is seeking Navy Nuclear Trained Junior Officers (111X and 112X, 1120 preferred) and Enlisted (MM, ET, EM) looking for their next career.  CAI was founded by Navy Nukes, and approximately 25% of our US team served in the Nuclear Navy before joining CAI.  Success as a Navy Nuke translates to a successful career with CAI.  Join us and put the hard work and training of your Navy days to good use with CAI. We have found that commissioning a ship fits perfectly into commissioning, qualifying and validating Pharmaceutical (BcX), Data Center (DcX) or other mission critical facilities and equipment.   We are 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.   We offer full-time positions 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.   Our employee owners are driven by the challenge and constant diversity of assignments, while having the stability of a company that has never experienced a lay off. On any given day our teams are responsible for a myriad of activities involved in starting up a facility, equipment or process including QA test document development, third party factory acceptance testing, on site inspections and tests, system 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 time zones, we sometimes travel to our client site for 10 days then return home for 4. Your location is not really critical as long as you're open to travel.    Requirements include:  Nuclear Trained Officers – qualified engineer and submarines Nuclear Trained Enlisted – qualified EWS and submarines 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. 

Pharmaceutical Consultant

July 12, 2020 1:15 pm || Published by

CAI is a 100% employee-owned company established in 1996, that has grown year over year to over 500 people worldwide. We provide quality, regulatory compliance, project management and other consulting services to FDA regulated and other mission critical industries. CAI is seeking motivated Consultants to support biotech and pharmaceutical projects across the country. These are full-time opportunities with competitive compensation and benefits which include: Long Term Disability and Life Insurance provided by the company. Health insurance at very low cost to employee, 15% retirement contribution, 24 days PTO, 5 sick days per year, and support for continued professional education. 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, FDA filings, quality system development, tech transfer, process engineering, QC Laboratory management, and various other operational readiness consulting for our clients.  The Consultant will be responsible for partnering with Clients to drive operational readiness through knowledge in environmental controls, QC Labs, process engineering, aseptic manufacturing, and strong project management. Ideally this consultant will have some exposure to Biologics and prior experience in growing Emerging Markets. This is a hands-on role that will require a proven ability to execute a client focused strategy while establishing strong, positive relationships with both client and internal teams.   Requirements include:  BS Degree in a Scientific or Technical Discipline/Life or Health Sciences preferred 10+ years of experience in Pharma Quality or Regulatory preferably at the Senior Manager or Associate Director+ level 1-2+ years in Aseptic Manufacturing is preferred Experience working cross functionally across Quality, Process Development, Tech Transfer and working with external leads in support of novel technologies Experience with Biological products is preferred Experience with Phase 1-3 programs with Orphan/Breakthrough/RMAT therapy designations Excellent oral and written communication skills in English  Able to travel domestically and internationally if required  Able to work overtime  Able to work in the US without sponsorship now or any time or in the future. 

QA Validation – SIP

July 12, 2020 1:14 pm || Published by

Our Clients are looking for us to fill some exciting, challenging and rewarding positions. Why not make 2020 your step-up year. Come and join a growing team of highly motivated and exceptionally skilled professionals. CAI offers you control of your career, your professional development, your growth and path to success.   Commissioning Agents, Inc. (CAI) is a rapidly expanding professional services organisation headquartered in the United States with offices in Ireland, Netherlands, Italy, Puerto Rico, Singapore, China and Malaysia. We work in the pharmaceutical, biotechnology, medical device, nutritional and building commissioning industries to provide industry best practices to our clients. We work in the areas of automation, commissioning and qualification, validation, maintenance and reliability, building commissioning, consulting and information management systems.   QA Validation - SIP Experienced in QA Validation activities   Review & approval of SIP thermal mapping and Performance Qualification validation protocols Extensive experience on writing and approving Deviations Technical writing experience for generation of protocols and reports. Essential Duties and Responsibilities include, but are not limited to, the following: Experience in Validation specifically Steam in Place Experience in KAYE validator usage Experience in review and approval of KAYE validator report and study runs, Experience in SIP thermal mapping, TC and BI placement Experienced Technical writer, Experience in Deviation writing, Troubleshooting to investigate issues if and when they occur. An excellent understanding of how manufacturing and steam sanitization and sterilization works Generate/review/Approval of SIP protocols, Generate Reports, Schedule of SIP activities with Manufacturing Liaise with numerous departments   In return for your skills and knowledge, CAI offers a wide range of benefits including: Health insurance, company paid critical illness insurance, Life Insurance, PRSA contribution and more Annual profit sharing Paid time off Continuing Professional Development and Education (internal and external) Opportunity to work abroad if desired

Data Center Commissioning Engineer

July 12, 2020 1:14 pm || Published by

Investment in data centres in will reach > €9 billion by 2021 in Ireland alone. Career growth to match your ambitions. Our Clients are looking for us to fill some exciting, challenging and rewarding positions. Why not make 2020 your step-up year. Come and join a growing team of highly motivated and exceptionally skilled professionals. CAI offers you control of your career, your professional development, your growth and path to success. The Data Center Commissioning Engineer at Commissioning Agents, Inc. leads and executes commissioning of data center critical systems including generators, CRAC, roof top AHUs, humidifier, pre-action and wet sprinkler systems, chillers, cooling towers, chill water pumps, exhaust fans and digital electrical distribution equipment.  This person is responsible for conducting reviews of client design packages, monitoring and analyzing FAT and First of Kind equipment Level 3 tests and developing O&M documentation to serve as a reference for data center mechanical equipment.  The Data Center Commissioning Engineer is critical in the company's continued success and growth by ensuring that testing has been executed and the client's data centers operate at maximum operational efficiency.   Commissioning Agents, Inc. (CAI) is a rapidly expanding professional services organization headquartered in the United States with offices in Ireland, Netherlands, Italy, Puerto Rico, Singapore, China and Malaysia.  We work in the pharmaceutical, biotechnology, medical device, nutritional and building commissioning industries to provide industry best practices to our clients.  All of our employees are full-time employees with benefits.  Check us out at www.commissioningagents.com.   The successful Data Center Commissioning Engineer must have: -Bachelor degree in Engineering or comparable experience -Minimum 3 years of experience in data center commissioning -Willing to do extensive travel -Strong knowledge of control systems such as BAS and EPMS -Project management experience -Understanding of Uptime Institute's Data Center Tier Classification system   In return for your skills and knowledge, CAI offers a wide range of benefits including: -Health insurance, company paid critical illness insurance, PRSA contribution and more -Annual profit sharing -Paid time off -Continuing education (internal and external) -Opportunity to work abroad if desired If you are interested and qualified for this position, please apply.

Lead C&Q Engineer/Project Manager

July 12, 2020 1:14 pm || Published by

Our Clients are looking for us to fill some exciting, challenging and rewarding positions. Why not make 2020 your step-up year. Come and join a growing team of highly motivated and exceptionally skilled professionals. CAI offers you control of your career, your professional development, your growth and path to success. The Lead C&Q Engineers / Project Managers at Commissioning Agents, Inc. will have at least 8 years experience in the Life Sciences C&Q arena.  This person is responsible for Planning, organising CQ activities in both Equipment and Data Integrity arena's, review and development of integrated schedules for validation activities, mentoring of team members, prep/review of CQ documents ( FAT, SAT, IQ, OQ, PQ report), future planning. PAI Readiness – Audit training, Remediation planning, Cross functional Mitigation planning and execution, mock audits, generation of summary reports at the client site.  Commissioning Agents, Inc. (CAI) is a rapidly expanding professional services organization headquartered in the United States with offices in Ireland, Netherlands, Italy, Puerto Rico, Singapore, China and Malaysia.  We work in the pharmaceutical, biotechnology, medical device, nutritional and building commissioning industries to provide industry best practices to our clients.   CAI is a 100% employee-owned company. All of our employees are full-time employees with benefits.   The successful Lead Commissioning and Qualification Engineer must have: -Bachelor degree in Life Science, Engineering, Computer Science, related discipline or comparable military experience -Minimum 8 years of experience in construction inspection, commissioning and qualification in a regulated industry -Willing to travel up to 100% of the time -Experience with commissioning and qualification protocols for utility, process and laboratory equipment in the pharmaceutical, medical device or biotech industry   In return for your skills and knowledge, CAI offers a wide range of benefits including: -Health insurance, company paid critical illness insurance, PRSA contribution and more -Annual profit sharing -Paid time off -Continuing education (internal and external) -Opportunity to work abroad if desired

Computer System Validation Engineer

July 12, 2020 1:14 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.    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 EU 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 

LIMS Co-Ordinator

July 12, 2020 1:14 pm || Published by

Our Clients are looking for us to fill some exciting, challenging and rewarding positions. Why not make 2020 your step-up year. Come and join a growing team of highly motivated and exceptionally skilled professionals.  CAI offers you control of your career, your professional development, your growth and path to success. We are currently hiring for a LIMS Co-Ordinator. This role would involve the following:- Work as a member of the project team to complete review of data builds for new system to ensure accuracy and completeness. Provide input to the data builders related to calculations, analysis, specifications and products. Participate in the business review for data building. Performance of UAT tests scripts. Review and approve data for production use. Change existing site SOPs to align with the new business processes as required by new application. Support business process remediation activities. Support End User Training and upskilling of laboratory personnel as required by project Commissioning Agents, Inc. (CAI) is a rapidly expanding professional services organization headquartered in the United States with offices in Ireland, UK, Netherlands, Italy, Puerto Rico, Singapore, China and Malaysia.  We work in the pharmaceutical, biotechnology, medical device, nutritional and building commissioning industries to provide industry best practices to our clients. CAI is a 100% employee-owned company. All our employees are full-time employees with benefits.   The successful LIMS Co-Ordinator must have: Experience working in a GMP laboratory facility. User/Application manager experience of one or more of the following applications Labware LIMS (V6), Empower, SAP Understanding of cGMP, 21 CFR Part 11, and regulations associated with pharmaceutical product manufacturing Effective written and verbal communication. Experience of working in a team focused on understanding the needs of key stakeholders such as, end users, system owners, managers, quality and software developers In return for your skills and knowledge, CAI offers a wide range of benefits including: Health insurance, company paid critical illness insurance, PRSA contribution and more Annual profit sharing Paid time off Continuing education (internal and external) Opportunity to work abroad if desired   If you are interested and qualified for this position, please apply directly through our website (search Europe positions) - please note applications will only be considered following completion of our online application form.

Artwork Change Quality Approval

July 12, 2020 1:14 pm || Published by

Our Clients are looking for us to fill some exciting, challenging and rewarding positions. Why not make 2020 your step-up year. Come and join a growing team of highly motivated and exceptionally skilled professionals.  CAI offers you control of your career, your professional development, your growth and path to success.   Commissioning Agents, Inc. (CAI) is a rapidly expanding professional services organisation headquartered in the United States with offices in Ireland, Netherlands, Italy, Puerto Rico, Singapore, China and Malaysia. We work in the pharmaceutical, biotechnology, medical device, nutritional and building commissioning industries to provide industry best practices to our clients. We work in the areas of automation, commissioning and qualification, validation, maintenance and reliability, building commissioning, consulting and information management systems.   Artwork Change Quality Approval   No. Of Roles – 5   Minimum Qualification – Degree in Science or Engineering   Minimum experience – Minimum 1 year experience in a pharmaceutical industry working with artwork management systems and artwork approvals. Experience with Quality review and approval of GMP documentation is required. Strong understanding of Regulatory requirements around artwork.   Role – Performs Quality approval of updated market package artwork (cartons, package inserts, labels) for pharmaceutical products in a validated artwork management IT system.   Location: Work will be executed using an ‘External Quality Assurance’ Model, this is remote work associated with sites in the UK, Netherlands, Belgium and East Coast US. Some travel may be required.    In return for your skills and knowledge, CAI offers a wide range of benefits including:   ·         Health insurance, company paid critical illness insurance, Life Insurance, PRSA contribution and more ·         Annual profit sharing ·         Paid time off ·         Continuing Professional Development and Education (internal and external) ·         Opportunity to work abroad if desired

Aseptic CQV Engineer with Biopharma CIP & Downstream Processing

July 12, 2020 1:14 pm || Published by

Our Clients are looking for us to fill some exciting, challenging and rewarding positions. Why not make 2020 your step-up year. Come and join a growing team of highly motivated and exceptionally skilled professionals.  CAI offers you control of your career, your professional development, your growth and path to success.   We are currently looking for a CQV Engineer with experience in CIP and Downstream Processing.   A range of positions to suit experienced (6+ years), Intermediate (2/3+ years) engineers are presently available.  We are also looking for Graduate Engineers who have worked or are presently in CQV Life Science placements.   The successful CQV Engineer must have: Bachelor's degree in Chemical, Mechanical or Biotech Engineering or equivalent discipline Proven track record with CIP and Downstream Processing Experience in aseptic processing manufacturing environments Experience in commissioning and qualification in the pharmaceutical industry Willing to travel Ability to conduct field inspections including piping and equipment walk downs, operational start-up and troubleshooting Subject matter expert and experience in either biotech, aseptic fill finish, OSD or clean utilities (WFI, clean steam, PW, CDA, Nitrogen, CIP, etc) Excellent oral and written communication skills in English   In return for your skills and knowledge, CAI offers a wide range of benefits including: • Health insurance, company paid critical illness insurance, PRSA contribution and more • Annual profit sharing • Paid time off • Continuing education (internal and external) • Opportunity to work abroad if desired

Project Leads/Project Managers

July 12, 2020 1:14 pm || Published by

Our Clients are looking for us to fill some exciting, challenging and rewarding positions. Why not make 2020 your step-up year. Come and join a growing team of highly motivated and exceptionally skilled professionals.  CAI offers you control of your career, your professional development, your growth and path to success.   Commissioning Agents, Inc. (CAI) is a rapidly expanding professional services organisation headquartered in the United States with offices in Ireland, Netherlands, Italy, Puerto Rico, Singapore, China and Malaysia. We work in the pharmaceutical, biotechnology, medical device, nutritional and building commissioning industries to provide industry best practices to our clients. We work in the areas of automation, commissioning and qualification, validation, maintenance and reliability, building commissioning, consulting and information management systems.   The Project Lead/Project Manager will be responsible for the design review, implementation and integration of Automation and Process Control systems based on industry standards. This person will be of Project Management level, have solid laboratory analytics and lab equipment validation experience, as well as a strong knowledge of I.T systems. We have a range of exciting Biopharma projects across Europe.   The successful Project Lead/Project Manager must have: Bachelor’s Degree in engineering or related discipline 10+ years’ experience in pharma at Senior/PM level Ability to integrate business systems with line control to automate machine operation and data transfer Demonstrated ability to independently create functional & cost-effective designs/processes that meet complex specification requirements Excellent written and verbal English communication skills Strong teamwork, leadership, communication, and organization skills Problem solving skills and the ability to perform root cause analysis   In return for your skills and knowledge, CAI offers a wide range of benefits including:   • Health insurance, company paid critical illness insurance, PRSA contribution and more • Annual profit sharing • Paid time off • Continuing education (internal and external) • Opportunity to work abroad if desired