VALIDATION ENGINEER IV
On-site · Bedford, New Hampshire, United States
Job Summary
The Validation Engineer IV conducts validation activities supporting cGMP pharmaceutical and medical device contract manufacturing. Responsibilities include authoring validation plans, overseeing development of specifications, reviewing lifecycle documentation, and coordinating validation activities across departments. The role requires strong knowledge of industry guidelines and regulations, excellent communication skills, and experience with commissioning and qualification in a cGMP environment. This position typically requires a Bachelors degree in Engineering or related discipline and at least eight years of relevant experience in the pharmaceutical industry.
Required Qualifications
- Bachelor’s degree in Engineering or related scientific discipline
- Minimum of eight (8) years of Pharmaceutical industry experience
- Experience in Validation, Quality, Production, or Engineering
- Combination of equipment qualification, process validation, or cleaning validation is acceptable
- Excellent technical writing, verbal communication and presentation skills
- Ability to evaluate compliance issues
- Strong skills in team development and leadership
Desired Qualifications
- Experience in pharmaceutical or biopharmaceutical environment
- Direct Validation experience with pharmaceutical or biopharmaceutical processes
- Validation experience with Thermal characterization, Vacuum physics, Heat and mass transfer, Formulation, Aseptic Filling and Lyophilization
- Knowledgeable in current industry standards and regulatory trends for Validation
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