Senior GMP Equipment Technician

Senior GMP Equipment Technician

Title: Senior GMP Equipment Technician

Location: Exton, PA

Full-time

Frontage Laboratories:

Frontage Laboratories Inc. is an award winning, full-service, CRO/Contract Research Organization operating over 25 state-of-the-art laboratories across the US, Canada and China. Our core competencies include drug metabolism, pharmacokinetics/ pharmacodynamics (PK/PD), safety and toxicology, bioanalytical services, chemistry and manufacturing controls for drug development, and core laboratory services for clinical trials.

Position/Job Summary:

We are seeking a highly hands-on Senior Equipment Technician to support the installation, maintenance, troubleshooting, and emergency repair of GMP pharmaceutical manufacturing equipment used in Sterile and non-sterile dosage manufacturing operations within a GMP-regulated, ISO-classified cleanroom environment.

This role is ideal for an experienced maintenance professional who enjoys working directly on equipment, solving mechanical and electrical problems, and responding quickly to critical manufacturing issues in a GMP-regulated environment.

Roles & Responsibilities:

Equipment Installation & Setup

• Lead installation, setup, and commissioning of GMP manufacturing equipment, including FAT/SAT (Factory/Site Acceptance Testing) and IQ/OQ support.
• Support equipment startup, change parts setup, alignment, calibration, and mechanical adjustments.
• Execute and document annual calibration, preventive maintenance (PM), and emergency repairs on production machinery.
• Coordinate with OEM vendors during major installations and repairs.
• Perform hands-on preventive maintenance (PM), corrective maintenance, and emergency troubleshooting on pharmaceutical manufacturing equipment.
• Rapidly diagnose and repair mechanical, electrical, pneumatic, hydraulic, and automation-related equipment failures.
• Support on-call and off-shift emergency maintenance activities when required.
• Minimize equipment downtime and restore manufacturing operations safely and efficiently.
• Complete maintenance documentation, work orders, logbooks, and calibration records accurately.
• Ensure all work complies with cGMP, safety, and company procedures.
• Support deviation investigations and corrective actions related to equipment issues.
• Maintain equipment in inspection-ready condition.
• Identify recurring equipment problems and recommend reliability improvements.
• Support spare parts inventory and preventive maintenance optimization.
• Assist in equipment upgrades and process improvement projects.

Required Equipment Experience

• Hands-on experience maintaining and troubleshooting pharmaceutical manufacturing equipment such as, Rotary tablet press, Fluid bed dryer/coater, Encapsulator, High shear granulator, Blender, Mixer, Aseptic filling line, Lyophilizer, Packaging line, CIP/SIP system, HVAC and clean utility system.
• Experience with OEM equipment such as Fette, Korsch, Bosch, IMA, Glatt, GEA, MG2, or similar equipment is strongly preferred.

Qualifications

• Technical school certification, technical training, or equivalent hands-on maintenance experience preferred.
• 5+ years of hands-on maintenance experience in pharmaceutical, biotech, or GMP-regulated manufacturing.
• Experience with electrical systems, motors, sensors, PLCs, and automation troubleshooting is highly desirable.
• Ability to read mechanical drawings, wiring diagrams, and equipment manuals.
• Experience working in cleanroom and GMP manufacturing environments preferred.

Required Skills

• Strong hands-on mechanical aptitude.
• Emergency troubleshooting and repair capability.
• Familiarity with GMP documentation practices.
• Ability to work independently with minimal supervision.
• Strong sense of urgency and ownership.
• Ability to lift equipment/heavy parts/tools and work around manufacturing equipment.
• Ability to work in cleanroom and gowning environments.
• May require weekend, overtime, or on-call support during critical operations.
• Ability to stand and work on the manufacturing floor for extended periods.

Salary and Benefits:

Frontage Laboratories offer a competitive compensation and benefits package including health and dental insurance, a 401(k) plan, disability insurance, and life insurance.

Frontage Laboratories Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, among other things, or status as a qualified individual with disability.