Contract / Temp to Direct / Direct Hire: Direct Hire
State: North Carolina
Country: United States
Zip or Postal Code: 27617
PCI provides Calibration, Commissioning & Consulting solutions to our clients across multiple regulated industries including biotechnology, pharmaceutical, medical device, food & beverage and more. We are seeking a CQV Senior Engineer to add to our growing company. This is a challenging and exciting position with an array of benefits that seek to provide our associates with a positive career experience. PCI is a great place to meet similarly skilled team members and become an integral part of the PCI family, working together to achieve success for our associates and provide quality services for our clients.
The Commissioning, Qualification and Validation (CQV) Senior Engineer reports directly to the Team Leader, Manager, or Director of the CQV Team, depending on the organizational structure. These positions are exempt. Up to 100% percent travel may be required.
CQV Engineers perform commissioning, qualification, and validation testing on manufacturing process equipment and instruments; author protocols, initiate controlled documentation, and provide client support for CQ projects either independently or as part of a larger team.
In addition to the above, Senior CQV Engineers initiate, develop, and lead CQV projects and/or teams (internal and at client sites) with both PCI and non PCI team members. They are accountable for CQ project initiation, inception, design, development, implementation, management, follow up, and maintenance.
To view a complete job description of the Senior CQV Engineer, click here.
Some of the Responsibilities / Assignments of a Senior CQV Engineer:
Performs commissioning, qualification, calibration, and validation testing on manufacturing process equipment and instruments.
Authors protocols, initiates controlled documentation in support of CQV projects.
Independently and with minimal oversight initiates, establishes, provides direction, execution, and follow up of commissioning, qualification, calibration, and validation projects.
Subject matter expert who provides high level direction, tactical thoroughness, reliability, strategic initiative and consistent follow-through.
Interfaces and networks with industry professionals through professional organizations i.e. ISPE, PDA, NCSL, or ASQ. Shares SME knowledge through presentations, training sessions, or meetings.
May implement controlled documentation systems in support of CQV projects.
Proactively assesses and evaluates situations to initiate and develop/revise design specs and engineering drawings to establish fit-for-purpose for systems.
Senior CQV Engineer skills required:
Subject-Matter-Expert (SME) with commissioning and qualification and proven history of successful implementation of various manufacturing and utility systems, CIP & SIP, autoclave validation, qualification of controlled temperature environments, process validation, cleaning validation, equipment qualification, and use of the Validator 2000 and/or Kaye Digistrip.
Proven project and people leader with exceptional skills in planning, organizing, and history of driving and delivering successful results.
Exceptional communication skills between Team members, clients, and project leads.
Industry expert on Regulatory issues and requirements, ability to convey and conform systems and processes.
Experience & Education Required for Senior CQV Engineer
BS in Engineering, Life Sciences, or equivalent training with six years of relevant project experience, eight years of applicable (Commissioning, Qualification or Validation) experience or the equivalent combination of education and experience. Subject Matter Expert (SME) quality system/life science manufacture industry experience is required. A current PE license is required.
MS in Engineering, four years of relevant project experience and six years of applicable (Commissioning, Qualification, or Validation) experience or the equivalent combination of education and experience. Quality system/life science manufacture industry experience is required. A current PE license is preferred.
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