Instrument Technician, Operations
- Durham, NC
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 Instrument 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.
- 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
- 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 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
- 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 | Successful candidate will be required to work an 8-hour weekday schedule until night shift is required (estimated to start Jan2021)
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
- 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 ...
In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth.
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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