Validation Engineer — Impact in Regulated Manufacturing

the-pivot-group-careers; Caledonia (MI); On-site; USD 67,000 - 112,000; Full time

Job summary

The Pivot Group Network in West Michigan recruits for a Validation Engineer based in Caledonia, MI. The position aims to lead validation activities for equipment, processes, and software in a regulated manufacturing setting.

Applicants should hold a Bachelor's degree in engineering or life sciences and have 3+ years in validation with GxP and FDA requirements (21 CFR Part 820, Part 211, Part 11). Strong analytical and cross-functional collaboration skills are essential.

Qualifications

• 3+ years of validation experience in a regulated manufacturing environment.
• Strong knowledge of GxP and FDA regulations.
• Experience developing, executing, and reviewing validation protocols and reports (IQ/OQ/PQ).

Responsibilities

• Develop, execute, and review validation protocols and reports for equipment, processes, and software.
• Perform risk assessments and generate validation plans based on regulatory requirements and industry best practices.
• Collaborate with cross-functional teams to ensure successful project execution and adherence to quality standards.
• Investigate and resolve deviations, non-conformances, and out-of-specification results during validation activities.
• Maintain and update validation documentation to ensure compliance with cGMP, FDA, and other regulatory guidelines.
• Provide technical expertise and guidance on validation strategies and requirements to various departments.
• Participate in internal and external audits, providing necessary documentation and support.
• Develop and deliver training on validation principles and procedures to manufacturing and quality personnel.

Skills

Validation experience

GxP knowledge

FDA regulations

IQ/OQ/PQ experience

Statistical analysis

Education

Bachelor's degree in Engineering or Life Sciences

Tools

IQ/OQ/PQ protocols

Job description

The Pivot Group Network in West Michigan recruits for a Validation Engineer based in Caledonia, MI. The position aims to lead validation activities for equipment, processes, and software in a regulated manufacturing setting.

Applicants should hold a Bachelor's degree in engineering or life sciences and have 3+ years in validation with GxP and FDA requirements (21 CFR Part 820, Part 211, Part 11). Strong analytical and cross-functional collaboration skills are essential.