Job at a glance
Job Title: GMP Manufacturing Technical Support Specialist Job Description 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. Responsibilities 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. Essential Skills 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