Sr. Tech, Maintenance

Merck•Durham, NC

3d•$77,700 - $122,300•Onsite

About The Position

The Senior Tech, Engineering is a member of the Engineering team providing technical support for a capital project start-up in Durham, North Carolina. The new facility will include end-to-end processing of drug substance and drug product, including biotech culture growth, harvest, lyophilization, product inspection, utilities, and warehouse operations. The successful candidate will support the installation, operation, maintenance, and troubleshooting of biopharmaceutical manufacturing equipment, including washers, autoclaves, tanks, bioreactors, filtration skids, filling lines, lyophilizers, and isolators. The role may include developing Standard Operating Procedures (SOPs) and preventative maintenance plans, completing SAP transactions, supporting validation testing, assisting root-cause investigations, and participating in change-control activities. The role involves regular collaboration with operations, quality, automation, technology, contractors, and other groups. The position follows a rotating 3/2/2 schedule with 12-hour day or night shifts. The employee must be available for an off-hours on-call rotation and weekend overtime as needed. Duties require cleanroom gowning and personal protective equipment, and involve lifting up to 50 pounds, climbing ladders and stairs, working on platforms and elevated equipment, and walking, bending, crawling, and stooping. The salary range is $77,700–$122,300. The successful candidate may be eligible for an annual bonus and long-term incentive, if applicable. Benefits include medical, dental, vision, and other insurance for employees and family; retirement benefits including a 401(k); paid holidays; vacation; and compassionate and sick days.

Requirements

High school diploma or GED equivalent.
At least 3 years of plant maintenance experience with knowledge of technical craft skills such as instrumentation, electrical, plumbing, advanced mechanical, HVAC, and/or multi-stage refrigeration systems.
Familiarity with regulatory requirements for GMP manufacturing operations.
Good oral and written communication skills.
Proficiency with computer systems and applications, including Microsoft Word, Excel, and Outlook; PLCs; and CMMS calibration and maintenance database systems.
Effective maintenance, troubleshooting, and problem-solving skills.
Willingness and ability to lift 50 pounds, climb ladders and stairs, work on platforms and elevated equipment, and walk, bend, crawl, and stoop.
Availability for the stated rotating 12-hour day or night schedule, off-hours on-call rotation, and weekend overtime as needed.

Nice To Haves

SAP experience related to plant maintenance and spare-parts procurement systems.
cGMP experience in a sterile, bulk, or finished pharmaceutical environment.
Experience authoring preventive maintenance and calibration job plans and managing spare parts.
Experience installing, operating, maintaining, and/or troubleshooting biopharmaceutical manufacturing equipment such as washers, autoclaves, skids, tanks, bioreactors, and filtration skids.
Ability to read P&IDs, electrical drawings, and blueprints.
Ability to manage multiple priorities and advance several tasks in parallel.
Knowledge of Allen-Bradley PLCs and Siemens Apogee BAS.

Responsibilities

Perform routine maintenance and troubleshoot complex process, support, utility, automated, clean-in-place, and maintenance equipment and systems.
Assist with calibration, automation, validation, and other testing as required.
Support equipment installation, operation, maintenance, and troubleshooting in biopharmaceutical manufacturing areas.
Develop Standard Operating Procedures and preventative maintenance plans as requested.
Complete SAP transactions and support validation testing, root-cause investigations, and change-control activities.
Identify, develop, and implement systems that enhance operations and engineering processes.
Adapt and implement departmental plans and priorities to address local business, service, and operational challenges.
Develop and execute engineering change requests as necessary.
Provide input to deviation investigations and interface with approvers.
Perform equipment maintenance and repair safely using Hazardous Energy Control Procedures.
Support safety initiatives, including shop-floor audits, lockout/tagout, and updates to Hazardous Energy Control Procedures.
Coordinate repair and maintenance schedules with other departments, contractors, and disciplines.
Support daily meetings, communicate information across the organization, and escalate issues as needed.
Serve as a subject matter expert during tours and provide training on system maintenance as needed.
Order and maintain spare parts for assigned process equipment.
Ensure inventory transactions are complete, timely, and accurate.
Identify and communicate cost-saving opportunities.
Wear required personal protective equipment and perform duties requiring cleanroom gowning.