Calibration Engineering Leader

Job Description
Job Description Position Brand Description:

This Lead Instrumentation/Calibration Technician position within the biopharmaceutical manufacturing facility duties must be performed in compliance with established company, department, and safety policies and procedures within a cGMP-regulated facility. The Lead Technician position is to minimize equipment downtime, support projects, and ensure that the needs of the internal customers are met. The required duties include execution of Preventative and Corrective/General/Emergency maintenance/calibration of instrumentation of the manufacturing systems (autoclaves, glassware washers, bioreactors, TFF skid, chromatography skids, vessels, etc.), calibration of associated instruments, installation of new equipment and general plumbing, and electrical work, operation of the HVAC and BMS systems, and other duties as assigned. All work is to be in compliance with cGMPs, safety and environmental requirements, and the Maintenance Program.

The objective of this position is to work with others and individually to ensure all work scheduled for the day is completed professionally and timely. Additionally, this position is responsible for ensuring all required documentation is complete, legible and meets Good Documentation Practices standards. This position is a leadership position within the Maintenance group. The position is expected to provide leadership, train other technicians in calibration/Instrumentation aptitude, and promote teamwork and collaboration within the group.

Key Objectives/Deliverables:

• Technical SME is able to perform calibration of instrumentation, mechanical, electrical, PLC/Controls, pneumatic, hydraulic maintenance and calibrations.
• Able to determine schedule, resources, spare parts, roadblocks, approximate cost (as required), RCA, and Improvements in equipment, systems and processes (SOP, JP, etc).
• Determines needs for process improvements and gains support for solution from customers, QA, HSE, Engineering and Management.
• Performs System/Process/Program/Schedule troubleshooting.
• Completes tasks and associated documentation following all requirements and mentors and teaches other technicians and Engineers.
• Acts as LOTO Lead, Project Lead for complex LOTO, PM and/or CM projects. Proactively identifies correct parts needed in order to assist technicians in the repair as efficient as is possible.
• Leads exchanges with customers and engineers to perform RCA to drive process or system improvements. Participates on a Safety Team and/or Process Team.
• Assist management with Deviation Investigations as applicable to process equipment and control systems.
• Act as mentor to less experienced technicians working in GMARS.
• Recommend improvements to department Facility Procedures and job plans.
• Oversee contractors as needed: provide training, secure escort, periodic safety inspection and compliance checks.
• Provide emergency response as needed to assist scheduling needs.
• Drives Met Group to ensure all standards are maintained and stored properly, drives the Met 5s program, works with MRO and Met Group to collect standards for routine external calibration.
• Ensures calibration standards are fully stocked and available for use in the field.
• Maintain 100% training records for all required training.
• Perform all aspects of the position by following cGMP’s and all Safety and environmental regulations.

• High School Diploma or equivalent, with 2 years vocational, industrial, trade school or apprentice program experience; or equivalent industry experience.
• 8-12 years instrumentation calibration hands-on experience.
• Must be able to communicate clearly and effectively, both written and verbally.
• Must be able to work independently and in a team environment.
• Ability to lift a minimum of 50lbs. and climb a ladder

1. Experience in a cGMP / Industrial environment preferred.

This is a nonexempt, hourly role with an anticipated compensation range of $35/hr - $59/hr.
This is a banded role, and candidates will be placed within the range based on experience, skills, internal equity, and market considerations.

Celltrion Branchburg, LLC offers a comprehensive benefits package that includes paid time off (holidays, vacation, and additional leave), medical, dental, and vision insurance, life insurance, a company-matched retirement savings plan, wellness programs, and short- and long-term disability coverage.

This role does not require travel but does include on-call responsibilities and shift work.

The scheduled hours are Monday through Friday, 6:00 a.m. to 2:30 p.m.

Relocation assistance is not available.

Celltrion is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

Monday through Friday, 6:00 a.m. to 2:30 p.m.