Lead Tech, Maintenance

MSD Malaysia; Durham (NC); On-site; USD 86,000 - 135,000; Full time

Job summary

MSD Malaysia in Durham, NC, is hiring a Lead Tech, Engineering for a capital project start-up. You will provide technical support for biopharmaceutical processing equipment across filling, lyophilization, isolation, and utilities, and assist with SOPs and PM plans.

The role requires hands-on maintenance, calibration, SAP transactions, validation support, and change control activities, with collaboration across operations, quality, automation and tech groups.

Qualifications

• GMP manufacturing knowledge and regulatory familiarity.
• Strong oral and written communication skills.
• Physical ability to lift up to 50 lbs and work on raised platforms.
• Experience with CMMS, PLCs, and plant maintenance.
• Ability to read technical drawings and wiring schematics.

Responsibilities

• Perform routine maintenance and troubleshoot complex process systems.
• Assist with calibration, automation validation and testing.
• Develop and implement SOPs and preventive maintenance plans.
• Support SAP transactions and change control activities.
• Collaborate across operations, quality, automation and other groups.

Skills

GMP awareness

PLC knowledge

CMMS experience

Technical troubleshooting

Microsoft Office

Education

Bachelor Degree in Engineering or Science

Associate degree + 2 years relevant experience

Tools

SAP

P&ID interpretation

Allen Bradley PLCs

Job description

Job Description

Are you looking for an exciting opportunity with a rapidly growing pharmaceutical manufacturer? If so, then this is the opportunity for you! The Lead Tech, Engineering is a member of the Engineering team providing technical support within a capital project start‑up in Durham, North Carolina. The new facility will include end‑to‑end processing of drug substance, drug product, including biotech culture growth, harvest, lyophilization, product inspection, utilities, and warehouse. The candidate will support the installation, operation, maintenance and/or troubleshooting of biopharmaceutical manufacturing equipment such as washers, autoclaves, tanks, bioreactors, filtration skids, filling lines, lyophilizers and isolators. Develops Standard Operating Procedures (SOPs) and Preventative Maintenance (PM) plans as requested. Responsible for SAP transactions, validation testing support, supporting root cause investigations and change control activities. Actively supports, participates and embraces an inclusive team culture including significant interaction with operations, quality, automation, technology, and other groups as required.

Key Duties

• Ability to perform routine maintenance tasks, work with and troubleshoot complex process systems, including but not limited to: Process Equipment (e.g. Filling Machine, Lophilizer), Support Equipment (e.g. washers, autoclaves, incubators), Utility Equipment (e.g. Clean steam generators, Water-For-Injection generation/distribution, reverse osmosis skids, compressed gas systems), Automated Systems (e.g. Distributed Control System (DCS), Programmable Logic Controllers (PLC)), Clean-In-Place (CIP) Systems, Maintenance Equipment (e.g. tools and calibration equipment)


• Assist with execution of calibration, automation, validation and additional testing, as required.


• Decisions are guided by policies, procedures and business plan; receives guidance from manager.


• Contributes to the performance and results of the department.


• Identifies and resolves technical and operational problems; collaborates with peers to resolve problems that cross into inter‑related units.


• Responsible for assisting in the identification, development, and implementation of new systems which enhances the operation and/or engineering processes.


• Adapts and implements departmental plans and priorities based on division scorecard to address local business, service and operational challenges.

Quality & Safety Compliance

• Develop and execute engineering change request (ECRs), as necessary.


• The successful candidate should be able to examine an issue from perspectives (safety, compliance, automation, equipment, process, and people) in order to best understand and identify root cause.


• Provide input to investigate deviations, with responsibility to interface with approvers.


• Efficient and safe maintenance and repair of equipment using Hazardous Energy Control Procedures.


• 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.


• Actively supports safety initiatives, including shop floor audits, lockout/tagout and Hazardous Energy Control Procedure updates.

Communication

• Interface with other departments, contractors and disciplines on scheduling repairs and maintenance of equipment/utility systems.


• Support daily meetings to facilitate flow of information up/down through the organization.


• Escalate issues as needed to ensure the right support/awareness is given to issues as they arise.


• Serve as a Subject Matter Expert (SME) during tours to provide area/process overview information to visitors/auditors upon request.


• Working as a SME, provide necessary training for system maintenance as needed.

Financial

• Order and maintain spare parts for assigned process equipment.


• Ensure inventory transactions are complete, timely, and accurate.


• Recognize and communicate opportunities for cost savings.

Education & Minimum Requirement

Bachelor Degree in Engineering, Science or an associate degree and 2 years experience in a production and/or calibration and/or maintenance background OR 6 years of plant maintenance experience with knowledge of technical craft skills (instrumentation, electrical, plumbing, advanced mechanical, HVAC, and/or multi‑stage refrigeration systems).

Required Experience and Skills

• Familiarity of regulatory requirements in accordance with GMP manufacturing operations.


• Good oral and written communication skills.


• Physical requirements – Must be willing and able to lift 50 lbs, climb ladders and stairs, work on platforms and equipment above floor level. Walking, bending, crawling, and stooping is 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.


• Effective maintenance, troubleshooting, and problem‑solving skills required.

Preferred Experience and Skills

• SAP experience related to plant maintenance and spare parts procurement systems.


• cGMP experience in a sterile, bulk or finished pharmaceutical environment.


• Experience authoring PM/calibration job plans and management of spare parts.


• Installation, operation, maintenance and/or troubleshooting experience with biopharmaceutical manufacturing equipment such as washers, autoclaves, skids, tanks, bioreactors, and filtration skids.


• Ability to read P&ID's, electrical drawings, blueprints, etc.


• Ability to manage multiple priorities and advance several tasks in parallel.


• Knowledge of Allen Bradley PLC’s, Siemens Apogee BAS.

Salary Range

The salary range for this role is: $85,500-$134,700. This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.

Benefits and Incentives

• Annual bonus and long‑term incentive, if applicable.


• Medical, dental, vision healthcare and other insurance benefits (for employee and family).


• Retirement benefits, including 401(k).


• Paid holidays, vacation, and compassionate and sick days.

Required Skills

• Building Automation Systems


• Building Automation Systems


• Competency Management


• Computerized Maintenance Management Systems (CMMS)


• Corrective Maintenance


• Electrical System Troubleshooting


• Equipment Maintenance


• HVAC Engineering


• HVAC Maintenance


• HVAC Systems


• Hydraulic Systems


• Instrumentation Systems


• Instrument Calibrations


• Inventory Management System


• Lockout Tagout


• Maintenance Scheduling


• Maintenance Services


• Manufacturing Equipment


• Manufacturing Maintenance


• Material Handling Equipment


• Mechanical Troubleshooting


• Parts Inventory


• Parts Sourcing


• People Management


• Plant Maintenance


• {+ 10 more}

Employee Information

• Employee Status: Regular


• Relocation: No relocation


• VISA Sponsorship: No


• Travel Requirements: No Travel Required


• Flexible Work Arrangements: Not Applicable


• Shift: 1st - Day


• Valid Driving License: No


• Hazardous Material(s): n/a


• Job Posting End Date: 10/15/2026


• *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Our company 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 we have codified our legacy for over a century. Our success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.