Senior Commissioning and Qualification Engineer
Apply NowCompany: Commissioning Agents Inc
Location: Hedgesville, WV 25427
Description:
The Commissioning and Qualification Engineer at Commissioning Agents, Inc. develops the documentation to support C&Q. This person is responsible for protocol execution, field verification and generation of summary reports at the client site. The Commissioning and Qualification Engineer is critical in the company's continued success and growth by providing the services to our clients that are key to our business.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.Are You Ready?
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 integrityWe serve each otherWe serve societyWe 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.The successful Commissioning and Qualification Engineer must have:Bachelor degree or higher in Chemical, Mechanical, Biotech, Pharmaceutics or Pharma Engineering.Minimum 5 years of experience in commissioning and qualification in the pharmaceutical industry.Willing to travel.Ability to generate commissioning and qualification protocols for multiple types of compounding equipment, integrated filling machines, closed stopper processing, clean utility equipment and other GMP utility, HVAC, Facility, Process Manufacture systems.Ability to conduct field inspections including piping and equipment walk downs, operational startup 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)Other requirement:lGood Knowledge of EU / PICS / FDA GMPlBe familiar with Microsoft software for document handling such as Word, Excel, Power Point, Visio, Project etc.lFamiliar with Auto CAD for drawing and reviewing.lGood at English for reading, speaking, writing. Can write English technical documents with English.lTeam worker and keep learner.lEasy to communicate and willing share.In return for your skills and knowledge, CAI offers a wide range of benefits including:Medical, dental, disability, company paid life insurance and morePaid time offContinuing education (internal and external)
#LI-KO1
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 integrityWe serve each otherWe serve societyWe 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.The successful Commissioning and Qualification Engineer must have:Bachelor degree or higher in Chemical, Mechanical, Biotech, Pharmaceutics or Pharma Engineering.Minimum 5 years of experience in commissioning and qualification in the pharmaceutical industry.Willing to travel.Ability to generate commissioning and qualification protocols for multiple types of compounding equipment, integrated filling machines, closed stopper processing, clean utility equipment and other GMP utility, HVAC, Facility, Process Manufacture systems.Ability to conduct field inspections including piping and equipment walk downs, operational startup 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)Other requirement:lGood Knowledge of EU / PICS / FDA GMPlBe familiar with Microsoft software for document handling such as Word, Excel, Power Point, Visio, Project etc.lFamiliar with Auto CAD for drawing and reviewing.lGood at English for reading, speaking, writing. Can write English technical documents with English.lTeam worker and keep learner.lEasy to communicate and willing share.In return for your skills and knowledge, CAI offers a wide range of benefits including:Medical, dental, disability, company paid life insurance and morePaid time offContinuing education (internal and external)
#LI-KO1