Validation Engineer – Hudsonville Area

The Pivot Group Careers; Hudsonville (MI); On-site; USD 74,000 - 113,000; Full time

Job summary

The Pivot Group Careers is actively building a network of Validation Engineers in Hudsonville, MI and surrounding Ottawa County. These roles emphasize leading validation initiatives, documenting processes, and collaborating with production, engineering, and quality teams to ensure compliance and reliability.

Candidates should have a Bachelor's degree in engineering or related field, experience writing validation protocols in manufacturing, and familiarity with GMP, ISO 9001, or FDA requirements.

Qualifications

• Bachelor’s degree in engineering or a related technical field.
• Experience writing and executing validation protocols in a manufacturing setting.
• Familiarity with quality standards such as GMP, ISO 9001, or FDA requirements.
• Strong technical writing and documentation skills.
• Ability to read schematics, specifications, and process diagrams.
• Experience with statistical analysis and test data interpretation.
• Certification in quality or validation such as CQE or CSQE.
• Background in medical device, pharmaceutical, or automotive manufacturing.
• Experience with automated test equipment and data acquisition systems.
• Knowledge of lean or Six Sigma methods.
• Experience with computer system validation and 21 CFR Part 11.

Responsibilities

• Support change control by assessing impact and revalidating as needed.
• Review and update standard operating procedures tied to validated processes.
• Write and execute validation protocols for equipment, processes, and software systems.
• Perform installation, operational, and performance qualification activities.
• Collect and analyze test data and document results in validation reports.
• Investigate failures and deviations and support root cause analysis.
• Maintain validation documentation to meet regulatory and quality standards.
• Coordinate validation schedules with production, engineering, and quality teams.

Skills

Engineering degree

Validation protocols

GMP ISO FDA

Technical writing

Reading schematics

Statistical analysis

Education

Bachelor’s degree in engineering or related field

Job description

Job Description:

Validation Engineer | Hudsonville, MI

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

Are you a detail-oriented professional with a passion for excelling as a validation engineer? The Pivot Group Network, a Michigan manufacturing-focused recruiting group, is dedicated to fostering meaningful relationships and supporting career advancement. We collaborate with leading companies in the Hudsonville area seeking experienced Validation Engineers.

We are building our network of talent in this field across Michigan’s manufacturing regions. 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.

This posting covers Validation Engineer opportunities with manufacturers based in and around Hudsonville in Ottawa County, within about 30 minutes of the city.

The Opportunity

We partner with organizations in the Hudsonville area that seek Validation Engineers. These companies are committed to building strong teams and look for professionals who can lead initiatives effectively. By connecting with The Pivot Group Network, you position yourself for roles that match your background and aspirations.

Usual Responsibilities

• Support change control by assessing impact and revalidating as needed.
• Review and update standard operating procedures tied to validated processes.
• Write and execute validation protocols for equipment, processes, and software systems.
• Perform installation, operational, and performance qualification activities.
• Collect and analyze test data and document results in validation reports.
• Investigate failures and deviations and support root cause analysis.
• Maintain validation documentation to meet regulatory and quality standards.
• Coordinate validation schedules with production, engineering, and quality teams.

Recommended Qualifications

• Bachelor’s degree in engineering or a related technical field.
• Experience writing and executing validation protocols in a manufacturing setting.
• Familiarity with quality standards such as GMP, ISO 9001, or FDA requirements.
• Strong technical writing and documentation skills.
• Ability to read schematics, specifications, and process diagrams.
• Experience with statistical analysis and test data interpretation.

Bonus Qualifications

• Certification in quality or validation such as CQE or CSQE.
• Background in medical device, pharmaceutical, or automotive manufacturing.
• Experience with automated test equipment and data acquisition systems.
• Knowledge of lean or Six Sigma methods.
• Experience with computer system validation and 21 CFR Part 11.

Job Titles That Should Apply

Computer System Validation Specialist, Regulatory Affairs Specialist, Quality Assurance Engineer, Quality Engineer, Process Validation Engineer, Equipment Qualification Engineer, Compliance Engineer, Manufacturing Quality Engineer, Test Engineer

Work Authorization

Applicants must be authorized to work in the U.S. without current or future visa sponsorship. Visa sponsorship is not available.

Required Skills:

Technical Writing Resume Offers Life Sciences Support Operational Excellence Salary Hiring Partnerships Recruiting Compensation Validation Continuous Improvement Manufacturing Writing Communication Skills Regulations Preparation Software Documentation Engineering Training Communication

Salary Package:

$ 74,000.00 – 113,000.00 (US Dollar)