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Commissioning & Verification SME

  1. All US
  1. Contract
Competitive
26462/ZM
  1. Commisions, Qualification and Validation
Date Posted08 Apr 2021
Commissioning & Verification SME (Remote)

The United States is a hive of activity for the Life Sciences Industry at present with no shortage of major expansion/ new build facilities. We have an exciting remote opportunity for a Commissioning & Verification SME to join a major project for a global pharmaceutical organisation, located in the East Coast, with great longevity of employment possibility.

Responsibilities:
  • Serve as the primary Commissioning & Verification (C&V) Subject Matter Expert for one of four project work streams (See Role Summary.)  Commissioning and Verification (aka Qualification) will follow the ASTM E2500 standard.
  • Effectively interact with leadership and partner with C&V Lead, Engineering Project Management, Automation, Maintenance, Operations, and Quality stakeholders to establish priorities and define the commissioning & verification requirements for the assigned workstream.  This would include documentation of critical aspects, risk assessments, verification testing strategy, and acceptance criteria.
  • Review of technical specification documents, drawings, and vendor design submittals (including FAT, SAT, IQ/OQ), with a specific focus on GMP-critical aspects and impact on commissioning & verification.
  • Review and assess vendor documentation and executed testing (e.g. FAT, SAT) for adherence to GMP and project requirements.
  • Lead and participate in development and execution of complete verification documentation in accordance with internal Quality Standards, cGMP requirements, and approved verification requirements / strategy related to the assigned work stream.
  • Collaborate with other work stream leads to ensure effective integrated verification strategy of integrated systems and equipment.
  • Provide or arrange for development of complete verification documentation in accordance with internal Quality Standards and cGMP requirements for assigned work stream.
  • Collaborate with matrix organization to optimize Change Control implementation and management.
  • Maintain a working familiarity with current industry best practices and cGMP requirements. Maintain technical skills in the latest techniques for project management and pharmaceutical processing technology.
  • Assist C&V Lead with the preparation of C&V status reports: include descriptions, justifications, cost estimates, budgets, schedules, analysis of alternatives, verification requirements, and other required information.

The ideal candidate will have:
  • Bachelor of Science in Technical Field (engineering, life science, or equivalent) from accredited institution.
  • Minimum 4 years technical experience.
  • Experience in a pharmaceutical / FDA-regulated manufacturing environment. A solid working knowledge of cGMP and facility/equipment validation requirements.
  • Communication Skills: Excellent oral and written communication skills, including presentations.
  • Ability to write clearly, concisely, and persuasively in a professional environment.
  • Demonstrated ability to interact effectively with all levels of the organization.
  • Demonstrated understanding of risk-based approach to commissioning & qualification.
  • Experience with testing of automated manufacturing equipment / systems (e.g., PLC-controlled).
For more information on this project / position, please apply with a copy of your up to date CV today! 


 





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