Validation Engineer - Drive GMP Compliance & Quality

the-pivot-group-careers; Charlotte (MI); On-site; USD 81,000 - 121,000; Full time

Job summary

The Pivot Group Network, a West Michigan manufacturing-focused recruiting group, partners with Charlotte-based manufacturers to identify a qualified Validation Engineer. You will develop and execute IQ/OQ/PQ validation protocols for equipment, processes, and software while ensuring cGMP and FDA compliance.

You will collaborate with R&D, Quality and Manufacturing teams, prepare reports, analyze data, address deviations, and maintain validation documentation throughout the lifecycle.

Qualifications

• Bachelor's degree required in engineering or life sciences.
• 3+ years in validation in regulated manufacturing.
• Experience authoring/executing validation protocols and reports (IQ/OQ/PQ).
• Strong cGMP and FDA regulation knowledge.
• Experience with risk-based validation and statistics.

Responsibilities

• Develop and execute IQ, OQ, PQ validation protocols for equipment, processes, and software.
• Perform risk assessments and generate validation plans.
• Analyze validation data, write reports, present findings to stakeholders.
• Investigate deviations and non-conformances during validation activities.
• Ensure compliance with cGMP, FDA regulations and internal standards.
• Collaborate with cross-functional teams to support new products and improvements.
• Maintain and update validation documentation throughout lifecycle.

Skills

Validation protocols & reports

cGMP/FDA knowledge

Risk-based validation

Data analysis & statistics

Mentoring/leadership

Education

Bachelor's degree in Engineering, Life Sciences or related field

Tools

Minitab/JMP

MES/SCADA/PLCs

Job description

The Pivot Group Network, a West Michigan manufacturing-focused recruiting group, partners with Charlotte-based manufacturers to identify a qualified Validation Engineer. You will develop and execute IQ/OQ/PQ validation protocols for equipment, processes, and software while ensuring cGMP and FDA compliance.

You will collaborate with R&D, Quality and Manufacturing teams, prepare reports, analyze data, address deviations, and maintain validation documentation throughout the lifecycle.