Senior Validation Engineer - GMP & CQV Expert

MilliporeSigma; Jaffrey (NH); On-site; USD 105,000 - 115,000; Full time

Benefits offered by this job

Health insurance

PTO

Retirement contributions

Job summary

MilliporeSigma in the United States is seeking a Validation Engineer III to execute complex validations and qualifications of manufacturing equipment, materials, and tests used in producing high-purity filters. The role emphasizes quality, safety, and adherence to cGMP standards, with leadership responsibilities for junior engineers.

You will collaborate across Manufacturing, Planning, and Quality Control to drive risk assessments, document CQV activities, and ensure projects meet objectives.

Qualifications

• Bachelor’s degree in STEM required; 5+ years in FDA-regulated facilities preferred.
• Experience leading validation of automated and manual assembly with ISO/good practices.

Responsibilities

• Lead complex validation of equipment, materials, and processes.
• Prepare and review CQV docs: DQ, FAT, IQ, OQ, PQ, and process qualification.
• Coordinate validation scheduling with Manufacturing, Planning and QA.
• Lead RCA and CAPA actions to prevent recurrence.
• Mentor team members and contractors on validation best practices.
• Represent Validation in audits and cross-functional reviews.

Skills

Validation expertise

Equipment qualification

cGMP knowledge

Cross-functional collaboration

Technical writing

Data analysis

Education

Bachelor’s Degree in STEM

Master of Science in STEM

Tools

Minitab

CAD software

Microsoft Office

Job description

MilliporeSigma in the United States is seeking a Validation Engineer III to execute complex validations and qualifications of manufacturing equipment, materials, and tests used in producing high-purity filters. The role emphasizes quality, safety, and adherence to cGMP standards, with leadership responsibilities for junior engineers.

You will collaborate across Manufacturing, Planning, and Quality Control to drive risk assessments, document CQV activities, and ensure projects meet objectives.