Validation Engineer — Regulated Manufacturing, Muskegon Area

the-pivot-group-careers; Muskegon (MI); On-site; USD 80,000 - 120,000; Full time

Job summary

The Pivot Group Network is seeking a Validation Engineer in Muskegon, MI to lead and optimize validation activities across equipment, processes and software. The successful candidate will design and execute IQ/OQ/PQ protocols, assess risk, and ensure adherence to FDA, ISO, and internal quality standards.

Applicants should have a Bachelor's degree in a relevant field and 3+ years in regulated manufacturing validation, with strong documentation and data analysis skills for reporting and

Qualifications

• Bachelor's degree in Engineering, Life Sciences, or related field.
• 3+ years of validation experience in regulated manufacturing (medical device, pharma, biotech).
• Experience authoring/executing IQ, OQ, PQ protocols and reports for equipment, processes and software.
• Strong knowledge of cGMP and FDA regulations (21 CFR Part 820, Part 210/211, Part 11) and ISO 13485.

Responsibilities

• Develop and execute validation protocols for equipment, processes, and software.
• Perform IQ, OQ, and PQ activities for new and modified manufacturing systems.
• Conduct risk assessments and develop mitigation strategies for validation activities.
• Analyze validation data, generate reports, and present findings to stakeholders.
• Ensure compliance with regulatory requirements (FDA, ISO) and internal quality standards.
• Investigate and resolve deviations and non-conformances related to validated systems.
• Maintain validation master plans and documentation throughout the lifecycle.
• Collaborate with cross-functional teams (R&D, Quality, Manufacturing) on validation efforts.

Skills

Regulatory knowledge

Statistical methods

Risk assessment

Documentation & reporting

Education

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

Tools

Minitab

JMP

SCADA

PLC/automation software

Job description

The Pivot Group Network is seeking a Validation Engineer in Muskegon, MI to lead and optimize validation activities across equipment, processes and software. The successful candidate will design and execute IQ/OQ/PQ protocols, assess risk, and ensure adherence to FDA, ISO, and internal quality standards.

Applicants should have a Bachelor's degree in a relevant field and 3+ years in regulated manufacturing validation, with strong documentation and data analysis skills for reporting and