GMP Manufacturing Technical Support Specialist

This role provides hands-on technical support in a regulated GMP manufacturing environment, focusing on equipment maintenance, troubleshooting, validation, and continuous improvement. You will support manufacturing operations by resolving equipment and process issues, executing maintenance and engineering activities, and ensuring compliance with GMP and quality standards. This position offers the opportunity to make a meaningful impact in the medical device and biologics space while gaining extensive experience with validation, equipment qualification, and regulated operations., * Support manufacturing operations by troubleshooting equipment, process, and production issues to minimize downtime and maintain product quality.

• Perform maintenance and engineering activities to keep equipment operating safely, reliably, and efficiently.
• Partner closely with Manufacturing, Quality, Maintenance, and Engineering teams to resolve technical challenges and improve processes.
• Assist with equipment startups, installations, and upgrades, ensuring proper commissioning and integration into existing systems.
• Contribute to continuous improvement projects focused on equipment performance, process robustness, and operational efficiency.
• Support validation and qualification activities for equipment and processes, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
• Participate in process validation and equipment qualification efforts, ensuring compliance with applicable regulations and internal procedures.
• Investigate deviations and nonconformances, identify root causes, and help implement corrective and preventive actions.
• Collect, organize, and analyze technical and process data to support troubleshooting, process optimization, and performance monitoring.
• Prepare and complete technical documentation, including reports, validation documents, and change control records, in alignment with GMP and quality standards.
• Provide hands-on technical support and guidance to production technicians during routine operations, startups, and troubleshooting activities.
• Participate in internal and external audits and inspections, helping demonstrate compliance with GMP, FDA, and other regulatory requirements.
• Support ongoing efforts to improve safety, quality, reliability, and compliance across the manufacturing environment.
• Assist with calibration and verification activities to ensure equipment and instruments remain within specified tolerances., This position is based in an FDA-regulated GMP manufacturing environment focused on medical device and biologics production. You will work primarily on a Monday through Friday, first-shift schedule, with occasional weekend hours as needed to support critical operations, maintenance, or validation activities. The environment includes a range of production and support 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. Work is hands-on and performed in controlled, regulated areas where adherence to GMP, safety procedures, and documentation standards is essential. The culture is described as laid-back yet highly professional, with a strong emphasis on collaboration, continuous improvement, and learning. Team members gain significant exposure to equipment troubleshooting, validation, GMP operations, and process optimization while contributing to technologies that help improve patients’ quality of li Job Type & Location, Planning Hoisting Operations Mentorship Coordinating Construction Data Centers Communication Subcontracting Pharmaceuticals Business Acumen Quality Control Project Schedules Project Management Electrical Systems Organizational Skills Submittals (Construction) Mechanical Electrical And Plumbing (MEP) Systems +0

Operations Leadership Automation Innovation Autoclaves Incubators Reliability Self-Starter Communication Investigation Biotechnology Commissioning Change Control Report Writing Purified Water Pharmaceuticals Problem Solving Medical Devices Steam Generators Internal Auditing Technical Support External Auditing Safety Procedures Biopharmaceuticals Process Validation Root Cause Analysis Statistical Analysis Process Optimization Equipment Maintenance Software Documentation Change Control Process Artificial Intelligence Technical Documentation Manufacturing Operations Engineering Design Process Good Manufacturing Practices Continuous Improvement Process Troubleshooting (Problem Solving), * Associate degree in a technical field.

• At least 2+ years of R&D-related equipment troubleshooting experience.
• Demonstrated experience in qualification, validation, commissioning, or manufacturing support for equipment and processes.
• Hands-on experience with equipment troubleshooting, including diagnosing mechanical, electrical, and process-related issues.
• Experience with validation and equipment qualification activities, including IQ/OQ/PQ.
• Proficiency with process validation concepts and practices in a regulated environment.
• Strong skills in root cause analysis and structured problem-solving for deviations and nonconformances.
• Experience creating and maintaining technical documentation, including report writing and validation documentation.
• Ability to perform statistical analysis and interpret data to support investigations and process improvements.
• Experience preparing root cause investigation reports and documenting corrective and preventive actions.
• Familiarity with change control processes and documentation requirements in a GMP or regulated environment.
• Experience with calibration activities and understanding of calibration requirements for manufacturing equipment and instruments.
• Ability to work as a strong self-starter and operate independently while contributing effectively to a collaborative team.
• Experience working in a regulated environment such as medical device, pharmaceutical, biotechnology, life science, or similar GMP setting.
• Comfort working within FDA-regulated and GMP-compliant operations.

Additional Skills & Qualifications

• Experience working in a GMP manufacturing environment.
• in medical device or FDA-regulated industries.
• Experience in pharmaceutical, biotechnology, or life science manufacturing environments.
• Exposure to validation and qualification activities specific to medical device or biologics manufacturing.
• 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.
• Interest in contributing to products and technologies that support nerve repair and improve patients’ quality of life.
• Desire to work in a collaborative, growth-oriented environment with opportunities to expand skills in troubleshooting, validation, and continuous improvement.
• Strong communication skills to collaborate with cross-functional teams and document technical findings clearly and accurately., 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., Mechanics Management Hand Tools Shift Work Electronics Calculators Coordinating Multitasking Prioritization Self-Motivation Lifting Ability Problem Solving Customer Service Microsoft Office Self Development Workflow Management Process Improvement Equipment Operation Valid Driver’s License Administrative Functions Business Support Systems Verbal Communication Skills Troubleshooting (Problem Solving), Writing Research Simulink Equities Simulations Market Data Communication Ancient History Effective Writing Systems Engineering Intelligence Analysis Systems Modeling Language Verbal Communication Skills Model Based Systems Engineering Top Secret-Sensitive Compartmented Information (TS/SCI Clearance) Command Control Communications Computers Intelligence Surveillance And Reconnaissance (C4ISR)

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