Sr GMP Process Mechanic

Abzena Inc.; Bristol Township (Bucks County); On-site; USD 65,000 - 95,000; Full time

Job summary

Abzena Inc. is seeking a GMP Mechanic to maintain and repair GMP manufacturing equipment, laboratory systems, and facility utilities in a regulated production setting.

You will work across Manufacturing, Engineering, Validation, Quality, and Laboratory Operations to ensure regulatory compliance and high equipment reliability. The role requires hands-on maintenance, preventive and corrective work, and participation in continuous improvement initiatives to support clinical and commercial

Qualifications

• High School Diploma or GED required.
• Minimum of 3 years of industrial maintenance in regulated environments.
• Experience troubleshooting mechanical process equipment.
• Ability to read mechanical drawings and P&IDs.
• Familiarity with CMMS systems.
• Strong knowledge of cGMP and GDP practices.

Responsibilities

• Perform planned preventative maintenance on GMP equipment and facility systems.
• Conduct corrective maintenance and emergency repairs to minimize downtime.
• Troubleshoot mechanical, pneumatic, and hydraulic equipment failures.
• Maintain equipment such as bioreactors, chromatography systems, and process vessels.
• Support installation, commissioning, and validation activities.
• Participate in root cause investigations and CAPAs.

Skills

Mechanical troubleshooting

Reading drawings

Documentation

cGMP knowledge

Teamwork

Communication

Microsoft Office

Education

High School Diploma or GED

Trade school certification or technical apprenticeship

Tools

CMMS (Blue Mountain)

CMMS Maximo

CMMS eMaint

Job description

With extensive experience in developing biologics and bioconjugates, we offer a seamless service delivered by fully integrated teams, from early discovery to commercial manufacturing.

Forward-thinking and committed, we find the best solution and use the right technologies to design, develop and manufacture your products to ensure we get vital medicines to patients quickly and safely.

We are dedicated to quality excellence. We are driven to get better treatments to market, efficiently and responsibly by reducing timelines and delivering the highest quality products and services.

We are Abzena. More than a CDMO, we are a responsible and dedicated partner that takes care of your products from concept to patient.

The GMP Mechanic is a critical member of the Facilities Maintenance team at Abzena and is responsible for performing preventative maintenance, corrective maintenance, troubleshooting, repair, and installation of GMP manufacturing equipment, laboratory equipment, facility systems, and supporting utilities. This hands‑on role ensures equipment reliability, regulatory compliance, and operational readiness to support clinical and commercial manufacturing operations.

The GMP Mechanic works closely with Manufacturing, Engineering, Validation, Quality, Laboratory Operations, and Facilities to execute maintenance activities while maintaining compliance with cGMP requirements, Good Documentation Practices, and company procedures. The position supports both GMP and non‑GMP operations and contributes to continuous improvement initiatives that improve equipment reliability, safety, and operational efficiency.

Responsibilities

• Perform planned preventative maintenance (PM) on GMP manufacturing equipment, laboratory equipment, and facility infrastructure.
• Perform corrective maintenance and emergency repairs to minimize equipment downtime.
• Troubleshoot mechanical, pneumatic, hydraulic, and process equipment failures.
• Maintain and repair manufacturing equipment including bioreactors, chromatography systems, TFF systems, process vessels, mixers, hold tanks, filling equipment, isolators, lyophilizers, clean steam equipment, autoclaves, and associated process equipment.
• Maintain facility equipment including HVAC systems, compressed air systems, purified water systems, WFI systems, clean steam generators, boilers, chillers, pumps, vacuum systems, and building utilities.
• Support maintenance activities within classified cleanrooms while following gowning procedures and contamination control practices.
• Execute work orders using the Computerized Maintenance Management System (CMMS), ensuring complete and accurate documentation.
• Follow Good Documentation Practices (GDP) and cGMP requirements when documenting maintenance activities.
• Support equipment installation, commissioning, qualification, and validation activities.
• Assist Engineering with equipment modifications and continuous improvement initiatives.
• Participate in root cause investigations, deviations, CAPAs, and change controls as required.
• Support internal, client, and regulatory inspections by providing maintenance documentation and technical expertise.
• Maintain spare parts inventory and recommend critical spare requirements.
• Read and interpret mechanical drawings, piping and instrumentation diagrams (P&IDs), equipment manuals, and technical documentation.
• Ensure all maintenance activities are performed safely and in accordance with OSHA, environmental, and company safety requirements.
• Support shutdown activities, equipment relocations, facility projects, and capital improvement initiatives.
• Participate in the on-call rotation to support manufacturing and facility operations outside normal business hours.
• Identify opportunities to improve equipment reliability, maintainability, and overall operational performance.

Qualifications

• High School Diploma or GED required.
• Technical trade school certification, military mechanical training, or equivalent mechanical apprenticeship preferred.
• Minimum of 3 years of industrial maintenance experience, preferably within pharmaceutical, biotechnology, medical device, or other regulated manufacturing environments.
• Experience troubleshooting mechanical process equipment in a GMP manufacturing environment.
• Working knowledge of pumps, valves, piping systems, gearboxes, conveyors, motors, bearings, seals, and rotating equipment.
• Experience with sanitary piping systems, hygienic process equipment, and stainless steel process systems preferred.
• Familiarity with HVAC systems and pharmaceutical utilities including compressed gases, purified water, clean steam, boilers, chillers, and process cooling systems.
• Experience using CMMS systems such as Blue Mountain, Maximo, eMaint, or equivalent.
• Ability to read mechanical drawings, equipment manuals, and P&IDs.
• Strong mechanical troubleshooting and root cause analysis skills.
• Working knowledge of cGMP regulations, Good Documentation Practices, and pharmaceutical maintenance practices.
• Ability to prioritize multiple assignments in a fast‑paced manufacturing environment.
• Strong communication and teamwork skills with the ability to work effectively across Manufacturing, Engineering, Validation, Quality, and Laboratory Operations.
• Basic computer proficiency including Microsoft Office.

Preferred Qualifications

• Associate degree in Mechanical Technology, Industrial Maintenance, Mechatronics, or related technical discipline.
• Experience supporting aseptic manufacturing operations.
• Experience with pharmaceutical process equipment and cleanroom environments.
• Welding, machining, or fabrication experience.
• Experience with calibration or instrumentation support.
• OSHA safety training or equivalent industrial safety certifications.

FLSA: Non-Exempt

Abzena is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws.

This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, and training.