Senior Validation Engineer - Regulated Manufacturing (CSV)

the-pivot-group-careers; Netherlands; On-site; EUR 63,000 - 97,000; Full time

Job summary

The Pivot Group Network in Holland, MI is seeking a Validation Engineer to develop and execute IQ/OQ/PQ protocols for manufacturing equipment, processes and software, ensuring compliance with FDA/ISO standards.

You will analyze data, write reports, support change control, and collaborate with R&D, Quality and Manufacturing to define validation strategies. Bachelor’s degree and 3+ years in regulated validation preferred.

Qualifications

• Bachelor's degree in Engineering, Life Sciences, or related field.
• 3+ years of validation experience in regulated manufacturing (medical device, pharma, biotech).
• Strong knowledge of GxP, FDA guidelines, ISO 13485, 21 CFR Part 820, Part 11.
• Proven ability to develop, execute, and summarize validation protocols (IQ/OQ/PQ).
• Experience performing risk assessments and root cause analysis.
• Excellent technical writing and communication skills.

Responsibilities

• Develop and execute validation protocols (IQ, OQ, PQ) for manufacturing equipment, processes, and software.
• Perform risk assessments and generate validation plans to ensure regulatory compliance.
• Analyze validation data, generate reports, and present findings to cross-functional teams.
• Investigate and resolve deviations or non-conformances identified during validation.
• Support change control by assessing validation impact of proposed changes.
• Maintain validation documentation in an organized, auditable manner.
• Collaborate with R&D, Quality, and Manufacturing to define validation strategies.

Skills

Excellent technical writing

Communication skills

GxP knowledge

Education

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

Job description

The Pivot Group Network in Holland, MI is seeking a Validation Engineer to develop and execute IQ/OQ/PQ protocols for manufacturing equipment, processes and software, ensuring compliance with FDA/ISO standards.

You will analyze data, write reports, support change control, and collaborate with R&D, Quality and Manufacturing to define validation strategies. Bachelor’s degree and 3+ years in regulated validation preferred.