Validation Engineer - Byron Center Area

the-pivot-group-careers; Michigan; On-site; USD 74,000 - 113,000; Full time

Job summary

The Pivot Group Network is partnering with Byron Center-based manufacturers to connect experienced Validation Engineers with current and future opportunities. This role focuses on validating equipment, processes, and software to ensure compliance and quality throughout the product lifecycle.

Candidates should have a Bachelor's in engineering or life sciences and 3+ years in regulated environments, with strong documentation skills and knowledge of GxP and FDA requirements.

Qualifications

• Bachelor's degree in Engineering, Life Sciences, or related field.
• 3+ years in validation within regulated manufacturing (medical device/pharma/biotech).
• Knowledge of GxP, FDA 21 CFR Part 11/Part 820, ISO 13485.
• Experience developing/ executing IQ, OQ, PQ for equipment, processes and software.
• Strong technical writing for validation documentation.

Responsibilities

• Develop, execute, and review validation protocols for equipment, processes, and software.
• Perform risk assessments and create validation plans for regulatory compliance.
• Analyze validation data, write reports, present findings to cross-functional teams.
• Investigate deviations and non-conformances in validation activities.
• Maintain master plans and schedules for timely validation completion.
• Collaborate with engineering/quality/production to integrate validation into product lifecycle.

Skills

GxP knowledge

FDA regulations knowledge

Validation protocol development

Education

Bachelor's degree in Engineering/Life Sciences or related

Tools

Minitab

JMP

PLC

SCADA

MES

Job description

Validation Engineer | Byron Center, MI

Salary Range: $74,000 - $113,000 depending on experience

Are you a dedicated 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 career growth. We partner with leading manufacturing companies in Byron Center, seeking experienced Validation Engineers to strengthen their teams.

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 Byron Center 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, execute, and review validation protocols for equipment, processes, and software.
• Perform risk assessments and generate validation plans to ensure compliance with regulatory requirements.
• Analyze validation data, write reports, and present findings to cross-functional teams.
• Investigate and resolve validation deviations and non-conformances.
• Maintain validation master plans and schedules, ensuring timely completion of validation activities.
• Collaborate with engineering, quality, and production teams to integrate validation into the product lifecycle.

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, biotech).
• Demonstrated knowledge of GxP, FDA regulations (e.g., 21 CFR Part 11, Part 820), and industry standards (e.g., ISO 13485).
• Proven experience in developing and executing validation protocols (IQ, OQ, PQ) for equipment, processes, and software.
• Strong technical writing skills for creating clear and concise validation documentation.

Bonus Qualifications

• Experience with statistical process control (SPC) and data analysis tools (e.g., Minitab, JMP).
• Familiarity with automation systems and software (e.g., PLC, SCADA, MES).
• ASQ certifications (e.g., CQE, CSSBB, CQA).
• Knowledge of cybersecurity principles in manufacturing environments.
• Experience with risk management methodologies beyond FMEA (e.g., HAZOP, 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, Validation Specialist, Validation Lead, Validation Consultant, QA Validation Engineer, Quality Assurance Validation Engineer, Compliance Engineer, Regulatory Affairs Engineer, Test Engineer, Verification Engineer