Senior Validation Engineer

4 weeks ago


King of Prussia, Pennsylvania, United States EPM Scientific Full time
CQV Engineer Job Description

We are seeking a highly skilled CQV Engineer to join our team at EPM Scientific in Philadelphia. Our client, a leading pharmaceutical company, is looking for an expert to support their operations in the development and distribution of innovative medications.

Key Responsibilities:

  • Perform Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) to ensure systems and equipment meet design and operational requirements.
  • Develop and execute protocols for Design Qualification, Factory Acceptance Tests (FATs), Site Acceptance Tests (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
  • King of Prussia, PA
  • W2 only

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