Maintenance Technician, Operations

Job Description

Our Company is expanding its global vaccine production network by investing $650 million and adding a 225,000-square-foot building within the footprint of the Maurice R. Hilleman Center for Vaccine Manufacturing in Durham, NC. The new facility will be used to produce the bulk active ingredient for a specific vaccine, comprised of fermentation, microfiltration/ultrafiltration, and chromatography steps.

The Maintenance Technician is accountable for providing equipment troubleshooting and maintenance support for a new product project/manufacturing operation. Develops standard operating procedures (SOP's) and preventative maintenance (PM's) plans, as requested. Accountable for written documentation of activities. Accountable for SAP transactions and change control activities including spare part lists and Preventative Maintenance (PMs) plans. Actively promotes, participates and embraces a team culture including significant interaction with Operations, Quality, Automation, Technology, and other groups as required.

Primary Responsibilities

• Maintain and execute scheduled maintenance and calibrations on Process Equipment (e.g. tanks/bioreactors, filtration skids, chromatography columns); Support Equipment (e.g. washers, autoclaves, tube welders/sealers); Utility systems (e.g. Clean steam generators, Water-For-Injection generation/distribution, reverse osmosis skids, vapor compression stills, compressed gas systems)
• Automated Systems (e.g. Distributed Control System (DCS), Programmable Logic Controllers (PLC), robotics)
• Clean-In-Place (CIP) Systems
• Maintenance Equipment (e.g. tools and testing equipment)
• Ability to work with and troubleshoot complex process systems to include bioreactors, filtration skids, chromatography columns, washers, autoclaves and CIP skids
• Routine maintenance tasks including but not limited to diaphragm replacement, equipment lubrication, filter changes, rotating equipment inspection, and adjustments to process equipment as needed
• Installation, testing, adjustment, maintenance, repair, and troubleshooting of complex automated process equipment
• Calibrate pressures, temperatures, PH, conductivity, weights, flows sensors etc.
• Develop 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 process equipment
• Interface with other departments, contractors and disciplines on scheduling repairs and maintenance of clean utility systems
• Assists with execution of calibrations, automation, validation and additional testing, as required
• Accountable for written documentation of activities
• Works within a team to perform maintenance and troubleshooting activities. Completes preventative maintenance and assists with calibrations, resolves deviations and evaluates equipment performance for efficient operation
• Efficient and safe maintenance and repair of equipment using Hazardous Energy Control Procedures, task-lists, and job safety guidelines
• Compliance with current good manufacturing procedures (cGMP), safety and environmental requirements/regulations/guidelines
• Required to wear personal protective equipment including safety glasses, earplugs, gloves, hard hats, safety harnesses, arc flash garments as needed, etc.
• Position requires clean room gowning during performance of some job duties (clean room safety shoes, clean room shoe coverings, clean room garments, hair coverings, safety glasses)
• 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.
• Routine shift will be 2-2-3, 12-hour night shift schedule, including holidays and alternating weekends | Will be available for an on-call schedule on nights and weekends.

Education Minimum Requirement

• High School Diploma/GED or higher

Required Experience and Skills

• Minimum of two (2) years of plant maintenance experience with knowledge of technical craft skills (instrumentation, electrical, advanced mechanical, HVAC, and/or multi-stage refrigeration systems
• Willing and able to lift fifty (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 good verbal and written communication skills
• Effective 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, or Electrical
• Working knowledge of regulatory requirements in accordance with GMP manufacturing operations
• 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
• GMP compliant maintenance database systems
• Calibration experience Knowledge of SAP, Delta V and Procal MaintInst Tech

NOTICE FOR INTERNAL APPLICANTS

In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor. #VETJOBS #EBRG MSJR TechnicianDurham

Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.

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U.S. Hybrid Work Model

Effective September 5,2023 our U.S. Hybrid work model will be as follows: 1. Three total days on site per week: Tuesday and Wednesday - plus one additional day of choice based on what works best for organizations and/or teams. 2. Fridays will formally be a remote-working day unless business critical tasks require onsite presence.

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Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status:
Regular

Relocation:
No relocation

VISA Sponsorship:
No

Travel Requirements:
10%

Flexible Work Arrangements:
Not Specified

Shift:
3rd - Night

Valid Driving License:
Yes

Hazardous Material(s):
N/A

Requisition ID:R249409