Validation Engineer - Manistee Area

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

Validation Engineer | Manistee, MI

Salary Range: $76,000 - $116,000 depending on experience

Are you a meticulous professional with a passion for excelling in validation engineer? The Pivot Group Network, a West Michigan manufacturing-focused recruiting group, is dedicated to fostering meaningful relationships and supporting career growth. We are collaborating with companies in Manistee seeking experienced Validation Engineers.

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 working with companies in Manistee that are adding Validation Engineers to their teams. These organizations value quality over speed in hiring. By connecting with us, you position yourself for opportunities that align with what you're looking for.

Key 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.

Recommended 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).
• Demonstrated knowledge of GxP regulations and industry standards (e.g., FDA 21 CFR Part 820, ISO 13485).
• Experience with various validation activities, including IQ, OQ, PQ for equipment, processes, and software.
• Strong technical writing skills for authoring and reviewing validation protocols and reports.

Bonus Qualifications

• Experience with Lean Manufacturing or Six Sigma methodologies.
• Familiarity with data analysis tools (e.g., JMP, Minitab, Python, R).
• Project management certification (e.g., PMP, CAPM).
• Advanced degree in a relevant engineering or scientific field.
• Experience with automation systems (e.g., PLC, SCADA, DCS).

Job Titles That Should Apply

Validation Engineer, Senior Validation Engineer, Principal Validation Engineer, CSV Engineer, Computer System Validation Engineer, Process Validation Engineer, Equipment Validation Engineer, Software Validation Engineer, Test Engineer (Validation), QA Validation Engineer, Validation Specialist, Validation Lead, Validation Consultant, Validation Analyst, Quality Engineer (Validation), Biomedical Engineer (Validation), Pharmaceutical Validation Engineer, Biotech Validation Engineer, Medical Device Validation Engineer

Why The Pivot Group Network

The Pivot Group Network was founded by manufacturing professionals who've been on both sides of the hiring process. Our clients are strategic—they partner with us because they want real insight into their roles and the people filling them, not a stack of resumes. We focus on match-driven placements built around what actually matters: Commute, Compensation, Culture, and Career trajectory.