Senior Validation Engineer – Manufacturing, Manistee, MI

the-pivot-group-careers; Michigan; On-site; USD 76,000 - 116,000; Full time

Job summary

The Pivot Group Network is assisting manufacturers in Manistee, MI by adding Validation Engineers to their teams. This role focuses on developing and executing IQ/OQ/PQ validation protocols for equipment and processes in a regulated manufacturing environment.

You will analyze data, write validation reports, ensure FDA/ISO compliance, and collaborate with R&D, Quality, and Manufacturing to drive compliant, repeatable validation activities.

Qualifications

• Bachelor's degree in engineering or a related scientific discipline.
• 3+ years of experience in validation within a regulated manufacturing environment (e.g., medical device, pharmaceutical).
• Knowledge of GxP regulations and industry standards (FDA 21 CFR Part 820, ISO 13485).
• Experience with IQ, OQ, PQ for equipment, processes, and software.
• Strong technical writing skills for validation protocols and reports.

Responsibilities

• Develop and execute validation protocols (IQ, OQ, PQ) for manufacturing equipment and processes.
• Perform risk assessments and generate validation plans for new and modified systems.
• Analyze data and author validation reports summarizing testing results and conclusions.
• Ensure compliance with regulatory requirements (e.g., FDA, ISO) and internal quality standards.
• Investigate deviations and out-of-specification results during validation activities.
• Support change control activities by assessing validation impact for proposed changes.
• Collaborate with cross-functional teams (e.g., R&D, Quality, Manufacturing) on validation efforts.

Skills

Strong technical writing

GxP regulations knowledge

Regulatory compliance understanding

Education

Bachelor's degree in engineering or related field

Tools

JMP

Minitab

Python

R

Job description

The Pivot Group Network is assisting manufacturers in Manistee, MI by adding Validation Engineers to their teams. This role focuses on developing and executing IQ/OQ/PQ validation protocols for equipment and processes in a regulated manufacturing environment.

You will analyze data, write validation reports, ensure FDA/ISO compliance, and collaborate with R&D, Quality, and Manufacturing to drive compliant, repeatable validation activities.