GMP Manufacturing Tech & Validation Specialist

Actalent; Vandalia (OH); On-site; USD 41,000 - 45,000; Full time

Benefits offered by this job

Medical benefits

Dental & vision

401(k) Retirement Plan

Life Insurance

Paid time off

Job summary

Actalent is seeking a GMP Manufacturing Technical Support Specialist to provide hands-on technical support in a regulated manufacturing setting. You will assist with equipment maintenance, troubleshooting, and qualification activities across medical device and biologics spaces.

The role involves IQ/OQ/PQ activities, deviation investigations, and collaboration with Manufacturing, Quality, and Engineering teams to drive process improvements.

Qualifications

• Associate degree in a technical field required.
• 2+ years of R&D-related equipment troubleshooting experience.
• Experience with qualification, validation, commissioning, or manufacturing support.
• Hands-on troubleshooting of mechanical, electrical, and process issues.
• Experience with validation activities including IQ/OQ/PQ.
• Process validation concepts in regulated environments.
• Strong root cause analysis and problem-solving skills.
• Ability to document technical findings clearly in reports.
• Statistical data interpretation for investigations and improvements.
• Familiarity with GMP/documentation requirements.

Responsibilities

• Troubleshoot equipment, processes, and production issues to minimize downtime.
• Perform maintenance and engineering activities for safe, reliable operation.
• Collaborate with Manufacturing, Quality, Maintenance, and Engineering teams to resolve challenges.
• Assist with equipment startups, installations, and upgrades.
• Participate in continuous improvement projects focused on performance and efficiency.
• Support validation and qualification activities (IQ/OQ/PQ).
• Assist in process validation and equipment qualification efforts.
• Investigate deviations and implement CAPAs.
• Analyze data to support troubleshooting and process optimization.
• Prepare technical documentation and validation records in line with GMP.

Skills

Regulatory compliance

Equipment troubleshooting

Validation & qualification

Root cause analysis

Documentation & reports

Cross-functional collaboration

Data analysis

Independent work

GMP environment

FDA inspections

Education

Associate degree in technical field

Tools

IQ/OQ/PQ

Job description

Actalent is seeking a GMP Manufacturing Technical Support Specialist to provide hands-on technical support in a regulated manufacturing setting. You will assist with equipment maintenance, troubleshooting, and qualification activities across medical device and biologics spaces.

The role involves IQ/OQ/PQ activities, deviation investigations, and collaboration with Manufacturing, Quality, and Engineering teams to drive process improvements.