Senior Validation Engineer — cGMP, IQ/OQ/PQ Expert

the-pivot-group-careers; Grand Haven (MI); On-site; USD 78,000 - 118,000; Full time

Job summary

The Pivot Group Network in Grand Haven, MI is seeking a Validation Engineer to develop and execute validation protocols for equipment, processes, and software. You will work with cross-functional teams to ensure compliance with cGMP and regulatory standards.

Candidates should have a bachelor's degree in engineering and 3+ years in validation within a regulated manufacturing environment, with strong knowledge of GxP, FDA regulations, and ISO 13485. Excellent technical writing is essential.

Qualifications

• Bachelor's degree in engineering or related field required.
• 3+ years of validation experience in regulated manufacturing (medical device/pharma).
• Strong knowledge of GxP, FDA regulations, and ISO 13485.

Responsibilities

• Develop, execute, and review validation protocols and reports for equipment, processes, and software.
• Perform risk assessments and generate validation master plans.
• Collaborate with cross-functional teams to align validation activities with timelines and regulatory requirements.
• Investigate and resolve deviations and non-conformances related to validation activities.
• Maintain and update validation documentation to ensure cGMP compliance.
• Participate in internal and external audits to present validation strategies and documentation.
• Provide technical expertise and training on validation principles and practices.

Skills

Validation protocols

IQ/OQ/PQ

Regulatory compliance

Technical writing

Cross-functional collaboration

Education

Bachelor's degree in engineering

Job description

The Pivot Group Network in Grand Haven, MI is seeking a Validation Engineer to develop and execute validation protocols for equipment, processes, and software. You will work with cross-functional teams to ensure compliance with cGMP and regulatory standards.

Candidates should have a bachelor's degree in engineering and 3+ years in validation within a regulated manufacturing environment, with strong knowledge of GxP, FDA regulations, and ISO 13485. Excellent technical writing is essential.