Validation Engineer

Syner-G BioPharma Group

Waltham, United States
Market competitive base salary; annual incentive p...
On-site
5-10 years cqv experience
Gmp facility systems validation
Iq oq pq protocol execution
The role combines facilities engineering ownership with Commissioning, Qualification, and Validation lifecycle execution to ensure GMP compliance

Job Summary

  • The role combines facilities engineering ownership with Commissioning, Qualification, and Validation lifecycle execution to ensure GMP compliance.
  • Syner-G is a strategic biopharma partner recognized for fostering a positive culture and providing significant career growth opportunities.
  • Candidates will lead validation efforts, manage risk assessments, and support inspection-ready operations across laboratory and manufacturing environments.

Matching Summary

The role combines facilities engineering ownership with Commissioning, Qualification, and Validation lifecycle execution to ensure GMP compliance.

Salary

Market competitive base salary; Annual incentive plan available; Benefits include development and recognition programs

Skills & Requirements

Must-have

  • 5-10 years CQV experience
  • GMP facility systems validation
  • IQ OQ PQ protocol execution
  • Risk assessment FMEA facilitation
  • CAPA and Change Control ownership
  • Facilities engineering troubleshooting

Nice-to-have

  • VanRx robotic isolator experience
  • Building Management Systems familiarity
  • CAPEX project experience
  • ISPE guidance knowledge
  • Mentoring junior staff capabilities

Key Requirements

  • Bachelor's degree in Engineering
  • 5-10 years CQV or facilities experience
  • Willingness to obtain specialty boiler license
  • Travel up to 100% required
  • FDA and EMA regulatory knowledge

Work Rights

Not specified

Tailored Resume

Cover Letter