Senior Validation Engineer: CQV & GMP Specialist

Millipore Corporation

Peterborough (NH)

On-site

USD 105,000 - 115,000

Full time

12 days ago

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Benefits offered by this job

Health insurance

Paid time off (PTO)

Retirement contributions

Other perquisites

Job summary

Millipore Corporation seeks an experienced Validation Engineer III to perform complex validations of equipment, materials, and processes for high-purity manufacturing. You will lead qualification activities, assess risk, and collaborate across Manufacturing, Planning, and Quality Control to ensure CGMP compliance.

The role requires mentoring junior engineers, driving project plans, and delivering CQV documentation (DQ/IQ/OQ/PQ).

Qualifications

Bachelor's degree in engineering, sciences, or related field with GMP exposure.
5+ years in FDA-regulated medical device or pharmaceutical manufacturing.
Experience leading validation of automated and manual processes with ISO/good engineering practices.

Responsibilities

Lead complex validations and qualifications of equipment, materials, and processes.
Coordinate validation execution with Manufacturing, Planning and Quality Control.
Prepare and review CQV documentation (DQ/IQ/OQ/PQ) and test results.
Mentor team members and contractors on validation strategies and cycle development.
Lead RCA and CAPA actions to prevent reoccurrence and improve processes.
Represent Validation during internal and external audits.