Validation Engineer - Allendale Area

the-pivot-group-careers; Allendale Charter Township (MI); On-site; USD 76,000 - 116,000; Full time

Job summary

The Pivot Group Network is actively seeking experienced Validation Engineers in Allendale, MI. This role focuses on developing and executing validation protocols for equipment, processes, and software in a regulated manufacturing environment.

Candidates should have 2+ years of validation experience, strong cGMP knowledge, and be able to support audits and cross-functional teams. Salary ranges reflect experience and market conditions in West Michigan.

Qualifications

• Bachelor's degree or higher in Engineering, Life Sciences, or related field.
• 2+ years of validation experience in regulated manufacturing (pharma/biotech/medical devices).
• Proficient in IQ/OQ/PQ validation for equipment, processes, and software.
• Strong knowledge of cGMP and FDA regulations (21 CFR 11, 210, 211, 820) and standards (GAMP 5, ICH Q7/Q9/Q10).

Responsibilities

• Develop and execute validation protocols (IQ, OQ, PQ) for equipment, processes, and software.
• Perform risk assessments and create validation plans.
• Analyze data and write validation reports with conclusions.
• Investigate validation deviations and non-conformances.
• Maintain validation documentation per regulatory requirements and internal procedures.
• Collaborate with R&D, Quality, and Manufacturing to ensure successful validation.
• Support internal and external audits by providing validation documentation.

Skills

IQ/OQ/PQ

Validation protocols

Regulatory compliance

Data analysis

Cross-functional collaboration

Audits support

Education

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

Tools

QMS

Deviation/CAPA management

Job description

Validation Engineer | Allendale, MI

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

Are you a seasoned professional with a passion for excelling in validation engineer? The Pivot Group Network, a West Michigan manufacturing-focused recruiting group, is committed to fostering meaningful relationships and supporting community growth. We are collaborating with leading companies in Allendale seeking Validation Engineers to lead and enhance their operations.

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 multiple companies in Allendale seeking experienced Validation Engineers. These organizations value long-term fit and are looking for professionals who bring both skill and alignment. By joining our network, you gain access to opportunities tailored to your goals.

Key Responsibilities

• Develop and execute validation protocols (IQ, OQ, PQ) for equipment, processes, and software.
• Perform risk assessments and generate validation plans.
• Analyze data and write comprehensive validation reports summarizing results and conclusions.
• Investigate and resolve validation deviations and non-conformances.
• Maintain validation documentation in accordance with regulatory requirements and internal procedures.
• Collaborate with cross-functional teams, including R&D, Quality, and Manufacturing, to ensure successful validation activities.
• Support internal and external audits by providing validation documentation and expertise.

Recommended Qualifications

• Bachelor's degree in Engineering, Life Sciences, or a related technical field.
• 2+ years of experience in validation within a regulated manufacturing environment (e.g., Pharma, Biotech, Medical Devices).
• Proficient in creating and executing validation protocols (IQ, OQ, PQ) for equipment, processes, and software.
• Strong understanding of cGMP, FDA regulations (e.g., 21 CFR Part 11, 210, 211, 820), and industry standards (e.g., GAMP 5, ICH Q7, Q9, Q10).
• Experience with Quality Management Systems (QMS) and deviation/CAPA management processes.

Bonus Qualifications

• Experience with statistical process control (SPC) and data analysis tools (e.g., MiniTab, JMP).
• Familiarity with automation systems and software (e.g., SCADA, PLC, MES).
• Knowledge of cybersecurity principles as they apply to manufacturing systems.
• Certified Quality Engineer (CQE) or similar professional certification.
• Experience with risk management frameworks (e.g., FMEA, PHA).

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, Quality Engineer, QA Engineer, Validation Specialist, Validation Lead, Validation Manager, GMP Validation Engineer, FDA Validation Engineer, Bio-Validation Engineer, Medical Device Validation Engineer, Pharmaceutical Validation Engineer, Biotech 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. Learn more at https://www.thepivotgroup.org.