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We are looking for a Senior Commissioning, Qualification, and Validation (CQV) Engineer to join our team on a
12-month contract
.
The Senior CQV Engineer is responsible for
ensuring systems, facilities, and equipment meet design requirements to be put
in place for a facility. The incumbent is also responsible and accountable for
the execution of the PSC mission, “to maintain the integrity and
professionalism of our products and services while enabling steady growth and
development.”

• 
  Act as a
  lead and simplify CQV functions, reports, and processes.
• 
  Support
  implementing safety programs for major capital projects.
• 
  Commission,
  qualify, and validate facilities, utilities, and/or equipment in assigned
  projects.
• 
  Initiates,
  authors, revises, reviews, and completes controlled documents for CQV projects.
• 
  Review
  and qualify equipment for commissioning, qualification, and validation
  activities.
• 
  Writes
  and reviews GMP and GDP documents and technical specifications.
• 
  Collaborate
  with multiple departments on assigned project activities and deliverables.
• 
  Initiate
  and coordinate risk analyses, design reviews, execute FAT/SAT, IQ, OQ, and PQ,
• 
  Contact
  and work with contractors and vendors on assigned projects.
• 
  Ability
  to travel as needed.
• 
  Additional
  duties and responsibilities may be assigned from time-to-time.

Requirements

• 
  Bachelor’s Degree in Engineering
  or Life Science.
• 
  7-10 years of applicable work
  experience in the biomedical and pharmaceuticals industry.
• 
  Proficient in authoring and
  executing DQ, FAT, SAT, IQ, OQ, PQ, and PV documents.
• 
  Proficient in developing SOPS,
  final reports and validation & quality policies.
• 
  Strong experience developing and
  executing CQV protocols.
• 
  Strong experience creating and
  maintaining CQV policies and processes.
• 
  Has good understanding and
  complies to cGMPs and CFR21 Part 11 guidelines.
• 
  Demonstrated strategic thinking
  and implementation skills; proven analytical skills with ability to translate.
  Data to actionable plans; demonstrated ability to develop and implement
  marketing and product/service. strategies by converting them into tactical
  marketing plans; execute and deliver results.
• 
  Excellent presentation and
  communication skills, written and oral, for a variety of audiences.
• 
  ​
  Highly organized in planning and
  time management, with the ability to multi-task.