If this position will be based in the US or Puerto Rico (not applicable to positions based outside of US or Puerto Rico): Subject to applicable law, all prospective hires will be required to demonstrate that they have been fully vaccinated for COVID-19 or intend to be vaccinated for COVID-19 by November 1, 2021, or qualify for a medical or religious accommodation to this vaccination requirement. Hired candidates who are not vaccinated by November 1, 2021, and who have not been approved for a legally-required medical or religious accommodation will be subject to disciplinary action up to and including termination of employment, subject to applicable law.
Our Manufacturing Operations teams are the people that make our products. We work in the manufacturing plants with a "Safety First, Quality Always" mindset striving for continuous improvement. We work in the local plant linked to our global manufacturing network to ensure the highest quality of raw materials, intermediates and finished products.
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.
We are hiring for a new manufacturing facility that is currently under construction. The successful candidate will initially be supporting the installation, start-up, and commissioning of this facility before transitioning to their eventual role as part of the maintenance team.
The Senior Instrumentation Technician is responsible for providing equipment troubleshooting and maintenance support for a new product facility/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)
Utility Equipment (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 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, including but not limited to: bioreactors, filtration skids, chromatography columns, washers, autoclaves and CIP skids
Routine calibrations including but not limited to Flow, Level, Temperature, Pressure, Humidity, Speed, and Process Analytical Instruments
Installation, testing, adjustment, maintenance, repair, calibration and troubleshooting of complex automated process equipment
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 assigned process equipment
Interface with other departments, contractors and disciplines on scheduling calibration and maintenance of equipment/utility systems
Assist with execution of maintenance, automation, validation and additional testing, as required
Responsible for written documentation of activities
Work 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 verbal
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.
Routine shift will be 2-2-3, 12-hour day shift schedule, including holidays and alternating weekends | Required to support an on-call schedule for off-days and weekends
Education Minimum Requirement
Required Experience and Skills
Minimum five years of plant maintenance experience with knowledge of technical craft skills (instrumentation, electrical, plumbing, advanced mechanical, HVAC, and/or multi-stage refrigeration systems)
Willing and able to lift 50 pounds, climb ladders and stairs, work on platforms and equipment above floor level. Walking, bending, crawling and stooping
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
Strategic leadership skills, and good verbal and written communication skills
Strategic and effective 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
Working knowledge of regulatory requirements in accordance with GMP manufacturing operations
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 calibration and/or maintenance database systems
Knowledge of SAP and Delta V
Our Manufacturing & Supply Division is committed to be the most trusted supplier of bio-pharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create an interdependent global manufacturing network that's committed to delivering a high quality, reliable supply to customers and patients on time, every time.
Who we are …
We are known as Merck & Co., Inc., Kenilworth, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.
What we look for …
Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us—and start making your impact today.
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.
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We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, 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
Flexible Work Arrangements:Not Specified
Shift:1st - Day, 3rd - Night
Valid Driving License:Yes
Number of Openings: 1