Lead Technician, Maintenance and Calibration

Job Description

The new manufacturing facility in Durham will play a critical role in the network of plants that produce life-saving medicines and vaccines, including our HPV vaccines.

Lead Maintenance Technician will be a leader with strong interpersonal, communication, and collaboration skills responsible for leads peers in supporting the manufacturing process. Individual will possess the ability to lead a team, train others and contribute to and implement process improvements.

The Lead Maintenance Technician is responsible for providing equipment troubleshooting, calibration, and maintenance support for a new product feasibility project/manufacturing support. 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)

• 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)

• Support to Digital Platforms (eg. SAP, ProCal, Brady)

• Initiate and complete routine calibration tasks, work with and troubleshoot complex process systems

• 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

• 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

• Decisions are guided by policies, procedures and business plan; receives guidance from manager

• Manage multiple priorities and advance several tasks in parallel

Must be flexible to perform all the following functions and other tasks, as needed:

• Ability to work with and troubleshoot complex process systems to include bioreactors, filtration skids, chromatography columns, washers, autoclaves and CIP skids.

• Installation, testing, adjustment, maintenance, repair, calibration and troubleshooting of complex automated process equipment.

• Develops 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 automation, validation and additional testing, as required

• Responsible for written documentation of 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 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 shift schedule, including holidays and alternating weekends. Required to support an on-call schedule for off-days and weekends.

Required Education, and Experience:

• High School Diploma/GED or higher

• Five (5) years of plant maintenance experience with knowledge of technical craft skills - primarily equipment maintenance, electrical and instrument calibration.

Preferred Experience and Skills:

• Degree in industrial systems, Mechanical, Electronics, Electrical, or Instrumentation

• 8 years of experience in plant maintenance/regulated manufacturing environment/GMP

• Installation, operation, maintenance, and/or troubleshooting experience with automated process equipment in the biopharmaceutical field

• Experience with GMP-compliant calibration and/or maintenance database systems.

• Knowledge of SAP, DeltaV, and ProCal

• Advanced mechanical, HVAC, and/or multi-stage refrigeration systems and plumbing

Physical Requirements:

• Willing and able to lift 50 pounds, climb ladders and stairs, work on platforms and equipment above floor level.

• Walking, bending, crawling and stooping are 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

Skills:

• Effective communication both written and oral

• Effective maintenance, troubleshooting, and problem-solving skills

• Working knowledge of regulatory requirements in accordance with GMP manufacturing operations.

• 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 strong leadership skills, and good oral and written communication skills.

• Strong planning, scheduling, and time management skills.

• Available for “On-Call” work rotation (during off-hours) and weekend overtime, as needed.

Our Manufacturing & Supply Division is dedicated to being the most trusted supplier of biopharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create a reliable global manufacturing network that’s devoted 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., Rahway, 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. #VETJOBS #EBRG MJSR 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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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.

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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:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Requisition ID:R238139