Manufacturing Validation Engineer — QA/Compliance (Hudsonville)

The Pivot Group Careers; Hudsonville (MI); Vor Ort; USD 74.000 - 113.000; Vollzeit

Zusammenfassung

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.

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

Engineering degree

Validation protocols

GMP ISO FDA

Technical writing

Reading schematics

Statistical analysis

Ausbildung

Bachelor’s degree in engineering or related field

Jobbeschreibung

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.