Senior Validation Engineer

About

We are seeking an experienced Validation Engineer with a strong background in biopharmaceutical or life sciences manufacturing environments. The ideal candidate will have hands-on experience with upstream process equipment and a solid understanding of validation practices.

Key Responsibilities

• Perform commissioning, qualification, and validation (CQV) activities for manufacturing equipment.
• Develop and execute validation protocols including IQ, OQ, and PQ.
• Work with upstream equipment such as:
  • Bioreactors
  • Pump skids
  • Buffer vessels
  • Other related process equipment (“upstream equipment”)
• Ensure compliance with GMP (Good Manufacturing Practices) and regulatory requirements.
• Collaborate with cross-functional teams including Engineering, Quality, and Manufacturing.
• Review and approve validation documentation and reports.
• Support deviation investigations, CAPA, and change control processes.

Required Qualifications

• Bachelor’s degree in Engineering, Life Sciences, or related field.
• 3+ years (or more) of validation experience in pharma/biotech industry.
• Hands-on experience with:
  • Bioreactors
  • Process skids
  • Buffer preparation systems
• Strong knowledge of CQV lifecycle and documentation practices.
• Familiarity with regulatory standards such as FDA, GMP, and ISO guidelines.

Preferred Skills

• Experience in upstream processing environments.
• Knowledge of automation systems (DeltaV, SCADA, etc.) is a plus.
• Strong problem-solving and documentation skills.