Lead Tech, Maintenance

Merck; Durham (NC); Presencial; USD 86.000 - 135.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Annual bonus

Long-term incentive

Medical, dental, vision coverage

401(k) retirement benefits

Paid holidays and vacation

Descripción de la vacante

Merck in Durham, NC seeks a Lead Tech, Engineering to support a capital project startup and biopharmaceutical manufacturing equipment. You will install, operate, maintain, and troubleshoot washers, autoclaves, tanks, bioreactors, and filling lines; develop SOPs and PM plans; perform SAP transactions and support validation and change control.

You will collaborate with operations, quality, automation and other groups, ensure safety and GMP compliance, and help drive continuous improvement in

Formación

• Familiarity with regulatory requirements in GMP manufacturing operations.
• Good oral and written communication skills.
• Physical requirements – able to lift 50 lbs, climb ladders/stairs, work on platforms/equipment above floor level; walking/bending/crawling/stooping required.
• Proficiency with Microsoft Office (Word, Excel, Outlook), PLCs, and CMMS database systems.
• Strong maintenance, troubleshooting, and problem-solving skills.
• Ability to work a 3/2/2 12-hour day shift; on-call rotation and weekend overtime as needed.

Responsabilidades

• Perform routine maintenance and troubleshoot complex process systems (e.g., Filling, Lyophilizer, CIP, utilities).
• Develop and execute calibration, automation, validation, and testing activities.
• Manage SAP transactions and support validation/change control activities.
• Collaborate with operations, quality, automation and other groups to resolve issues.

Conocimientos

GMP familiarity

Strong communication

Physical fitness

PLCs & CMMS

Troubleshooting

Shift work

Educación

Bachelor Degree in Engineering or Science

Associate degree + 2 years experience

6 years plant maintenance experience

Herramientas

CMMS Database Systems

SAP

Allen Bradley PLCs

Siemens Apogee BAS

Descripción del empleo

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
• Routine shift will 3/2/2 12 hour day Available for "On-Call" work rotation (during off-hours) and weekend overtime, as needed.

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.

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.

The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of benefits. Available benefits include 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}

US And Puerto Rico Residents Only

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities.

Requirements

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts

San Francisco Residents Only:

We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only:

We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance

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

Requisition ID

R417995