GMP Service Engineer

Yoh Services LLC; Bridgewater (MA); On-site; USD 38,572 - 55,104; Full time

Job summary

Yoh Life Sciences in Bridgewater, NJ is seeking a Service Engineer to support GMP biotech equipment. The role focuses on preventive maintenance, calibrations, retrofits, repairs, and troubleshooting in a GMP process environment.

The position is a 4-month contract with potential extension, requiring a 40-hour workweek on-site. Pay ranges from $35 to $40 per hour DOE. A Bachelor's in engineering and 3+ years GMP experience are required.

Qualifications

• Bachelor’s degree in engineering or related field.
• 3+ years’ GMP manufacturing experience, preferably cell therapy or biopharma.
• Basic GMP knowledge and strong documentation skills.
• Experience as a technical/service lead on multi-subsystem installs/qualifications.
• Proficient in troubleshooting and repairing complex manufacturing equipment.
• Ability to read engineering drawings and documents.

Responsibilities

• Perform installations, routine maintenance, and troubleshooting in a GMP cell therapy facility.
• Collaborate with cross-functional teams to ensure GMP compliance.
• Execute EOL testing, calibrations, and support validation testing.
• Respond to equipment failures and implement corrective actions to minimize downtime.
• Conduct preventive maintenance and maintain CMMS logs.
• Manage parts orders and coordinate with owners for scheduling.
• Maintain tools and calibration status; support CAPA investigations.
• Draft and maintain SOPs and work instructions.
• Participate in after-hours on-call rotation as required.

Skills

Verbal communication

Written communication

Organizational skills

Interpersonal skills

Team collaboration

Education

Bachelor’s degree in engineering or related field

Tools

Blue Mountain CMMS

PLC automation

Robotics (6-axis)

Job description

Yoh Life Sciences is hiring for a highly motivated Service Engineer in Bridgewater, NJ. The individual will contribute significantly to the success of service maintenance, repair, and support for biotech equipment in a GMP environment. The primary focus of this position will be to perform preventive maintenance, retrofits, upgrades, repairs, calibration, and troubleshooting of GMP process equipment.

Title: Service Engineer

Shift: M-F 8-5pm

Pay: $35-40/hr DOE

Duration: 4 month contract with opportunity to extend

Responsibilities

• Perform installations, routine maintenance, and troubleshooting of process equipment within a Good Manufacturing Practice (GMP) environment in a cell therapy manufacturing facility
• Collaborate with cross-functional teams to ensure compliance with GMP standards and regulations
• Perform equipment End of Line testing, calibrations, and support validation testing to meet quality and regulatory requirements
• Respond promptly to equipment failures and implement corrective actions to minimize downtime.
• Execute preventive maintenance activities to ensure optimal functionality of manufacturing equipment
• Maintain accurate documentation of all maintenance activities and equipment logs in a Computerized Maintenance Management System (CMMS)
• Manage parts ordering and coordinate with equipment and area owners to schedule maintenance activities
• Maintain tools and test equipment, and ensure they are properly calibrated and in good, safe working condition
• Collaborate with manufacturing and quality control teams to address technical issues and optimize processes
• Support Quality Change Controls and CAPA investigations
• Stay updated on industry trends and advancements to contribute to continuous improvement initiatives
• Participate in training programs to enhance technical skills and knowledge
• Participate in an after-hours on-call rotation to support GMP facility operations is required and managed through PagerDuty
• Experience drafting and maintaining Standard Operating Procedures (SOPs) and Work Instructions (WIs)

Requirements

• Bachelor’s degree or equivalent in engineering or a related field
• 3+ years’ experience in a GMP manufacturing environment, preferably in cell therapy or biopharmaceuticals
• Basic understanding of GMP regulations and quality standards
• Experience as a technical/service lead on a multi-subsystem installation/qualification
• Proficient in troubleshooting and repairing complex manufacturing equipment
• Ability to read and understand technical documents and engineering drawings
• Excellent organizational and documentation skills
• Ability to work collaboratively in a team-oriented environment
• Demonstrated ability and eagerness to learn complex automated manufacturing workflows; able to develop a working knowledge of the Cell Shuttle, BPS, and SLTS end-to-end process to support accurate triage and root cause identification
• Effective communication skills to interact with diverse stakeholders
• Must be able to work a full-time, 40-hour workweek, including weekends, and holidays, as required to support business needs
• Attendance at the plant site is considered an essential function
• Detail-oriented with a commitment to maintaining high-quality standards
• Must be able to lift and carry up to 50 lbs
• Excellent verbal, written, organizational, presentation, and interpersonal skills.

• Self-awareness, integrity, authenticity, and a growth mindset.

Nice to Haves

• Experience with PLC automated control systems
• Experience with 6 axis robots
• Experience working safely with high voltage systems (208V)
• Experience with Blue Mountain CMMS

Estimated Min Rate: $28.00

Estimated Max Rate: $40.00

What’s In It for You?

We welcome you to be a part of the largest and legendary global staffing companies to meet your career aspirations. Yoh’s network of client companies has been employing professionals like you for over 65 years in the