C&Q Engineer

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.