CQV Engineer

2 weeks ago


King of Prussia, United States EPM Scientific Full time

We are working with a leading pharmaceutical company that are looking for someone to join their team as a CQV Engineer in Philadelphia. The company has grown to become a key player in the development and distribution of innovative medications with a strong focus on treatments for chronic diseases such as diabetes, cardiovascular conditions, and neurological disorders.


Key Responsibilities:

  • Perform IQ, OQ and PQ to ensure systems and equipment meet design and operational requirements.
  • Prepare and execute protocols for Design Qualification, FATs, SATs and other validation activities.
  • Document and prove that systems impacting product quality and patient safety are correctly installed and function as expected.
  • Develop and execute validation protocols to ensure consistent and reproducible results.
  • Conduct systematic start-up of manufacturing systems.
  • Verify that equipment is installed as specified and functions properly.
  • Ensure systems are ready for operational use.
  • Create and maintain detailed records of validation activities.
  • Ensure compliance with industry guidelines and regulatory standards
  • Generate, review, and edit Standard Operating Procedures (SOPs).
  • Document impact and risk assessments.


Requirements:

  • 2-5 years of experience in Commissioning, Qualification, and Validation (CQV) within pharmaceutical, biotech, or GMP manufacturing environments.
  • Practical experience in a GMP facility in roles such as Process Engineering, Facilities, or Operations is advantageous.


Contractual Details

  • 40 Hours per week
  • 12 month contract with potential for extension
  • Start date: ASAP
  • King of Prussia, PA
  • W2 only


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