Key Responsibilities

• 
  Plan, coordinate, and execute commissioning, qualification, and validation activities for GMP systems and equipment.

• 
  Develop and review qualification protocols, test documentation, and validation reports.

• 
  Writes and
  revise
  GMP and GDP documents and technical specifications.

• 
  Support FAT, SAT, commissioning, and qualification activities throughout the project lifecycle.

• 
  Support
  development of
  SOPs and review final reports.

• 
  Collaborate with Engineering, Quality, Manufacturing, and Project teams to ensure successful project delivery.

• 
  Mentoring and providing consultation to the client and local team.

• 
  Ensure compliance with cGMP requirements, regulatory standards, and company quality systems.

• 
  Responsible for managing project activities and timelines.

• 
  Provided status reports of projects to the PSC Project Manager.

Requirements:

• 
  Bachelor Degree in Engineering, Science, or
  a related
  discipline.

• 
  5+
  years’ experience within pharmaceutical, biotechnology, medical device, or other GMP-regulated environments.
• 
  Experience applying a risk-based CQV (Commissioning, Qualification & Validation) approach.
• 
  Proficient in authoring and executing DQ, FAT, SAT, IQ, OQ, PQ, and PV documents.

• 
  Proficient in developing SOPS, final
  reports
  and validation & quality policies.

• 
  Understanding,
  developing,
  executing
  and maintaining CQV procedures and policies.

• 
  Experience performing temperature mapping of Controlled Temperature Chambers (CTCs) using systems such as Kaye Validator and/or Testo.

• 
  Experience performing temperature mapping and qualification of benchtop autoclaves.

• 
  Experience with digital validation platforms, preferably
  Kneat
  .