Validation Engineer - Holland Area

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

Validation Engineer | Holland, MI

Salary Range: $72,000 - $111,000 depending on experience

Are you a dynamic leader with a passion for excelling in validation engineer? The Pivot Group Network, a West Michigan manufacturing-focused recruiting group, is dedicated to building meaningful connections and supporting community growth. We are collaborating with leading companies in Holland seeking experienced Validation Engineers to drive results.

We are building our network of talent in this field across West Michigan and the broader manufacturing region Pivot Group Network serves. Our partner companies may or may not have an immediate opening for this exact role today, but we actively look for skilled professionals in the regions where they operate. If there is alignment now or in the near future, we reach out.

The Opportunity

We are collaborating with manufacturing firms in Holland that are seeking skilled Validation Engineers. These organizations are dedicated to maintaining high standards and are looking for professionals who can contribute effectively. By joining our network, you position yourself for opportunities aligned with your career goals.

Key Responsibilities

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

Recommended Qualifications

• Bachelor's degree in Engineering, Life Sciences, or a related technical field.
• 3+ years of experience in validation within a regulated manufacturing environment (e.g., medical device, pharmaceutical, biotechnology).
• Strong knowledge of GxP regulations, FDA guidelines, and industry standards (e.g., ISO 13485, 21 CFR Part 820, Part 11).
• Proven experience in developing, executing, and summarizing validation protocols (IQ, OQ, PQ) for equipment, processes, and software.
• Demonstrated ability to perform risk assessments and root cause analysis.
• Excellent technical writing and communication skills.

Bonus Qualifications

• Experience with Computer System Validation (CSV) in an FDA-regulated environment.
• Familiarity with GAMP 5 guidelines.
• Knowledge of statistical process control (SPC) and data analysis techniques.
• Certified Quality Engineer (CQE) or similar professional certification.
• Experience with risk-based validation approaches.

Job Titles That Should Apply

Validation Engineer, CSV Engineer, Computer System Validation Engineer, Process Validation Engineer, Equipment Validation Engineer, Software Validation Engineer, Validation Specialist, Senior Validation Engineer, Lead Validation Engineer, Principal Validation Engineer