CSV Engineer

February 18, 2020 7:21 am || 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. 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 CSV placements. The Computer System Validation (CSV) Engineer at Commissioning Agents, Inc. will author and execute protocols and test scripts.  This person is responsible for authoring GxP computer validation and CFR 21 Part 11 related documentation such as assessments, plans, URS, FRS and summary reports.  The CSV Engineer is critical in the company's continued success and growth by providing the services to our clients that are key to our business. Experience in Delta V is a distinct advantage.   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.  Check us out at www.commissioningagents.com.   The successful CSV Engineer must have: -Bachelor degree in Engineering, Computer Science or related discipline -Experience with computer system validation -Experience working in a GMP environment -Experience with GAMP, AGILE and SCRUM -Excellent written and verbal English communication skills 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.  

LIMS Co-Ordinator

February 18, 2020 7:21 am || 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.

Data Center Commissioning Engineer

February 18, 2020 7:21 am || 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.

CQV Engineer with Biopharma CIP & Downstream Processing

February 18, 2020 7:21 am || 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 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

CQV Engineer

February 18, 2020 7:21 am || 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.  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. 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. We work in the areas of automation, commissioning and qualification, validation, maintenance and reliability, building commissioning, consulting and information management systems. The successful  Commissioning, Qualification and Validation Engineer must have: -Bachelor degree in Chemical, Mechanical or Biotech Engineering -Experience in commissioning and qualification in the pharmaceutical industry -Ability to generate commissioning and qualification protocols for multiple types of compounding equipment, integrated filling machines, closed stopper processing and clean utility equipment -Ability to conduct field inspections including piping and equipment walk downs, operational start-up and troubleshooting  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 If you are interested and qualified for this position, please apply.

Quality Engineer

February 18, 2020 7:21 am || 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 Quality Engineer with 3-5 years’ experience in a Biopharma environment. The Quality Engineer 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. The successful Quality Engineer must have: -Bachelor’s degree in a science or equivalent discipline -Proven track record in Quality and Compliance. -Professional Quality Assurance Accreditation desirable -3-5 years' experience within GMP regulated facilities -Experience with Aseptic manufacture desirable -Pharmaceutical Compounding experience desirable -Experience of batch record review and product release essential -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

Lead C&Q Engineer/Project Manager

February 18, 2020 7:21 am || 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

Automation Project Manager

February 18, 2020 7:21 am || 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 Automation 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.   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 Automation Project Manager will lead the delivery of Automation Projects as part of the project portfolio. Projects objectives include productivity improvements to the operation and efficiency of control systems currently active in commercial use; and expansion of the current production capabilities with new process equipment and utilities. The Automation Project Manager must be able to develop and control scope, schedule and budget; follow a change management framework; act as liaison between the site, Global Engineering, and the Integrator; be the voice for the site to the Integrator, direct oversight of the contractor resource utilization and capabilities.   Automation Projects include: upgrades to equipment and software, checkout and installation of new equipment, augmenting existing automated functionality, and developing historian / reporting solutions.   Work with network architecture team to help develop further the PCN (Process Control Network) and servers, including VLAN switching architecture, server software update and patch management, virtualization, PLC software version control / repository, and database/historian management, and redundancy.   The Automation Project Manager must be able to work with a variety of different systems, have solid understanding mechanical and electrical systems, and strong troubleshooting abilities.    Requirements include:  BS in Electrical/Controls Engineering or Computer Science or equivalent experience 5+ years’ Experience in a regulated manufacturing environment (FDA) Knowledge of PLC’s, S-88 Batch, database development and maintenance, OSI PI Historian, HMI/SCADA development, Virtual Machine and Host configuration, Ethernet switching and VLANS, Server OS and management Experience with Allen Bradley Logix 5000 PLCs and Wonderware systems preferred Strong troubleshooting skills Excellent teamwork and communication skills in a team-oriented environment Proficient in computer skills and MS Office applications Ability to read and understand P&ID’s Always demonstrate ability to adhere closely to Standard Operating Procedures, adhere to schedules, interface in a constructive manner with vendors, contractors, associates, peers and managers. Frequent inter-organizational and outside customer contacts.  Represents the organization in providing solutions to complex technical issues associated with specific projects. 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 & Qualification Engineer w/ CSV Experience

February 18, 2020 7:21 am || 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 with CSV experience 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. CSV experience includes developing and executing protocols and test scripts.   Requirements include:  BS in a science or engineering field or equivalent years of experience 3 or more 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. Experience with PLC, MES, Delta C, PI is a plus. Using Rockwell, GE, Emerson, ABB, Werum, Siemens, Honeywell and other associated platforms if helpful. 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

Data Center Commissioning Engineer – Netherlands

February 18, 2020 7:21 am || 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 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 will join our team in the Netherlands and 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.