GMP Manufacturing Technical Support Specialist

This role provides hands-on technical support in a GMP manufacturing environment by executing maintenance and engineering activities, troubleshooting equipment and process issues, supporting validation efforts, and driving continuous improvement while ensuring compliance with GMP and quality standards. You will work closely with cross-functional teams in a regulated medical device and biologics setting, directly contributing to technologies that improve patients’ quality of life., * Support manufacturing operations by troubleshooting equipment, process, and production issues to minimize downtime and maintain safe, reliable performance.

• Perform maintenance and engineering work on production and support equipment to keep systems running safely and efficiently.
• Partner with Manufacturing, Quality, Maintenance, and Engineering teams to resolve technical challenges and ensure aligned solutions.
• Assist with equipment startups, installations, upgrades, and continuous improvement projects to enhance operational efficiency and reliability.
• Support validation and qualification activities (IQ/OQ/PQ) for equipment and processes, ensuring they meet regulatory and quality requirements.
• Investigate deviations and nonconformances, perform root cause analysis, and help implement corrective and preventive actions.
• Collect and analyze data to support troubleshooting, process improvements, and overall operational performance monitoring.
• Complete technical documentation accurately and on time, ensuring full compliance with GMP, FDA, and internal quality standards.
• Provide hands-on technical support and guidance to production technicians, helping them resolve equipment and process issues.
• Participate in audits and inspections, and contribute to ongoing efforts to improve safety, product quality, and equipment reliability.
• Support change control, calibration, and process validation activities as part of maintaining a robust and compliant manufacturing environment.
• Contribute to continuous improvement initiatives focused on equipment performance, process robustness, and documentation quality., Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools. Related Jobs Quality Engineer Actalent

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• At least 2+ years of equipment troubleshooting experience in a manufacturing or technical environment.
• Experience in qualification, validation, commissioning, or manufacturing support for equipment and processes.
• Hands-on experience with technical documentation, including writing, updating, and maintaining records in a regulated setting.
• Strong troubleshooting skills with the ability to diagnose and resolve equipment and process issues efficiently.
• Experience with validation and equipment qualification activities, including IQ/OQ/PQ protocols.
• Proficiency in root cause analysis and implementation of corrective and preventive actions.
• Experience working within GMP and quality-controlled operations.
• Ability to work independently as a strong self-starter within a laid-back, yet highly regulated culture.
• Comfort working in a regulated environment such as medical device, pharmaceutical, biotechnology, life science, or FDA-regulated manufacturing.
• Ability to create and maintain clear, accurate technical documentation supporting validation, qualification, and change control activities.

Additional Skills & Qualifications

• Experience in a GMP manufacturing environment.
• Exp. in medical device, pharmaceutical, biotechnology, or other FDA-regulated industries.
• Familiarity with process validation, change control, and calibration activities in a regulated setting.
• Hands-on experience troubleshooting, diagnosing, or qualifying equipment such as biosafety cabinets, incubators, peristaltic pumps, bar sealers, autoclaves, automated parts washers, clean steam generators, purified water systems, facility utilities, and label printers.
• Ability to collaborate effectively with cross-functional teams, including Manufacturing, Quality, Maintenance, and Engineering.
• Strong analytical skills for data collection and analysis to support process improvements and operational performance.
• Interest in continuous improvement initiatives related to equipment reliability, GMP operations, and documentation practices.
• Motivation to work in an environment focused on innovative nerve repair technologies and improving patients’ quality of life.
• Desire to grow professionally through hands-on experience with equipment troubleshooting, validation, and GMP operations., Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.