Validation Engineer: GMP & Compliance Focus

the-pivot-group-careers; Allendale Charter Township (MI); On-site; USD 76,000 - 116,000; Full time

Job summary

The Pivot Group Network is actively seeking experienced Validation Engineers in Allendale, MI. This role focuses on developing and executing validation protocols for equipment, processes, and software in a regulated manufacturing environment.

Candidates should have 2+ years of validation experience, strong cGMP knowledge, and be able to support audits and cross-functional teams. Salary ranges reflect experience and market conditions in West Michigan.

Qualifications

• Bachelor's degree or higher in Engineering, Life Sciences, or related field.
• 2+ years of validation experience in regulated manufacturing (pharma/biotech/medical devices).
• Proficient in IQ/OQ/PQ validation for equipment, processes, and software.
• Strong knowledge of cGMP and FDA regulations (21 CFR 11, 210, 211, 820) and standards (GAMP 5, ICH Q7/Q9/Q10).

Responsibilities

• Develop and execute validation protocols (IQ, OQ, PQ) for equipment, processes, and software.
• Perform risk assessments and create validation plans.
• Analyze data and write validation reports with conclusions.
• Investigate validation deviations and non-conformances.
• Maintain validation documentation per regulatory requirements and internal procedures.
• Collaborate with R&D, Quality, and Manufacturing to ensure successful validation.
• Support internal and external audits by providing validation documentation.

Skills

IQ/OQ/PQ

Validation protocols

Regulatory compliance

Data analysis

Cross-functional collaboration

Audits support

Education

Bachelor's degree in Engineering, Life Sciences, or related field

Tools

QMS

Deviation/CAPA management

Job description

The Pivot Group Network is actively seeking experienced Validation Engineers in Allendale, MI. This role focuses on developing and executing validation protocols for equipment, processes, and software in a regulated manufacturing environment.

Candidates should have 2+ years of validation experience, strong cGMP knowledge, and be able to support audits and cross-functional teams. Salary ranges reflect experience and market conditions in West Michigan.