Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where Merck has codified its legacy for over a century. Merck’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.
Merck Manufacturing Division, MMD, is a team of dedicated, energetic individuals who are committed to being the most trusted supplier of pharmaceuticals and health products worldwide. Our facilities, along with our external contractors, suppliers, and partners, comprise an interdependent global manufacturing network that’s committed to delivering a compliant, reliable supply to customers and patients on time, every time, across the globe.
The Lead Maintenance Technician is responsible for providing equipment troubleshooting and maintenance support for a new product feasibility project/manufacturing operation. Develops standard operating procedures (SOP's) and preventative maintenance (PM's) plans, as requested. Responsible for written documentation of activities. Responsible for SAP transactions and change control activities including spare part lists and Preventative Maintenance (PMs) plans. Actively supports, participates and embraces an inclusive team culture including significant interaction with Operations, Quality, Automation, Technology, and other groups as required.
Responsible for supporting:
- Process Equipment (e.g. tanks/bioreactors, filtration skids, chromatography columns)
- Support Equipment (e.g. washers, autoclaves, tube welders/sealers)
- Automated Systems (e.g. Distributed Control System (DCS), Programmable Logic Controllers (PLC), robotics)
- Clean-In-Place (CIP) Systems
- Maintenance Equipment (e.g. tools and calibration equipment)
Must be flexible to perform all the following functions and other tasks, as needed:
- Ability to work with and troubleshoot complex process systems to include bioreactors, filtration skids, chromatography columns, washers, autoclaves and CIP skids.
- Installation, testing, adjustment, maintenance, repair, calibration and troubleshooting of complex automated process equipment.
- Develops standard operating procedures (SOPs), engineering change request (ECRs), preventative maintenance (PM) plans/calibration procedures, task lists, etc., as required.
- Order and maintain spare parts for assigned process equipment
- Interface with other departments, contractors and disciplines on scheduling repairs and maintenance of clean utility systems
- Assists with execution of automation, validation and additional testing, as required
- Responsible for written documentation of activities
- Works within a team to perform maintenance and troubleshooting activities. Completes preventative maintenance and calibration work orders, resolves deviations and evaluates equipment performance for efficient operation.
- Efficient and safe maintenance and repair of equipment using Hazardous Energy Control Procedures
- Compliance with current good manufacturing procedures(cGMP), safety and environmental requirements/regulations/guidelines
- Effective communication both written and oral
- Physical requirements – Must be able to lift 50 lbs, climb ladders and stairs, work on platforms and equipment above floor level.
- Walking, bending, crawling, and stooping is required.
- Required to wear personal protective equipment including safety glasses, earplugs, gloves, hard hats, safety harnesses,etc.
- Position requires clean room gowning during performance of job duties
- Effective maintenance, troubleshooting, and problem-solving skills required
- Ability to manage multiple priorities and advance several tasks in parallel
- Demonstrated mechanical aptitude
- Proficient in the use of general hand and power tools, instruments and testing apparatus commonly used in maintenance and instrumentation.
- Ability to read P&ID's, electrical drawings, blueprints, etc.
- Required to support an on-call schedule to include days, nights and weekends on a rotational basis with other team members
Education Minimum Requirement:
- High School Diploma/GED or higher
Required Experience and Skills:
- Minimum of 4 years of plant maintenance experience with knowledge of technical craft skills (instrumentation, electrical, plumbing, advanced mechanical, HVAC, and/or multi-stage refrigeration systems) or 2 years with a Bachelor Degree.
- Working knowledge of regulatory requirements in accordance with GMP manufacturing operations.
- Willing and able to lift 50 pounds, climb ladders and stairs, work on platforms and equipment above floor level. Walking, bending, crawling and stooping are required.
- Proficiency in computer systems and applications including but not limited to: Microsoft Office (Word, Excel and Outlook), Programmable Logic Controllers (PLCs), CMMS Calibration/Maintenance Database Systems.
- Must demonstrate strong leadership skills, and good oral and written communication skills.
- Strong planning, scheduling, and time management skills.
- Available for “On-Call” work rotation (during off-hours) and weekend overtime, as needed.
Preferred Experience and Skills:
- Associate Degree in Industrial Systems, Mechanical, Electronics, Electrical or Instrumentation
- Experience working in a clean room or GMP/regulated manufacturing environment
- Installation, operation, maintenance and/or troubleshooting experience with automated process equipment in the biopharmaceutical field
- Experience with GMP compliant calibration and/or maintenance database systems.
- Knowledge of SAP and DeltaV
Your role at Merck is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At Merck, we’re inventing for life.
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Visa sponsorship is not available for this position.
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