Validation Engineer – Kentwood Area

The Pivot Group Careers; Kentwood (MI); On-site; USD 78,000 - 118,000; Full time

Job summary

The Pivot Group Network in Kentwood, MI is seeking a Validation Engineer to lead and execute validation activities across equipment, processes, and software systems. This role involves coordinating validation schedules with production, engineering, and quality teams, and maintaining rigorous documentation to meet GMP, ISO, and FDA expectations.

Ideal candidates hold a Bachelor's in engineering with experience writing validation protocols in manufacturing settings, plus familiarity with

Qualifications

• Bachelor's degree in engineering or a related technical field.
• Experience writing and executing validation protocols in a manufacturing setting.
• Familiarity with GMP, ISO 9001, or FDA requirements.

Responsibilities

• 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.
• 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.

Skills

Minitab

Statistical analysis

GMP ISO FDA

Technical writing

Validation protocols

Quality standards

Manufacturing QC

Education

Bachelor's degree in engineering

Tools

Python

R

Data acquisition systems

Validation software

Job description

Job Description:

Validation Engineer | Kentwood, MI

Salary Range: $78,000 – $118,000 depending on experience

Are you ready to take on a challenging and rewarding opportunity in validation engineer? The Pivot Group Network, a Michigan manufacturing-focused recruiting group, is committed to building meaningful connections in manufacturing. We partner with leading companies in the Kentwood area seeking 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 Kentwood in Kent County, within about 30 minutes of the city, including Lowell and Ada.

The Opportunity

We partner with organizations in the Kentwood 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

• 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.
• 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.

Recommended Qualifications

• Ability to read schematics, specifications, and process diagrams.
• Experience with statistical analysis and test data interpretation.
• 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.

Bonus Qualifications

• Experience with computer system validation and 21 CFR Part 11.
• 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.

Job Titles That Should Apply

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

Minitab Resume Data Offers Life Sciences Lean Six Sigma Support Six Sigma Regulatory Requirements Assurance Analysis Compliance Salary Hiring Partnerships Recruiting Compensation Validation Reviews Programming Languages R Manufacturing Quality Assurance Automation Programming Regulations Preparation Data Analysis Software Documentation Engineering Python Project Management Management

Salary Package:

$ 78,000.00 – 118,000.00 (US Dollar)