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Job Details


Merck & Co, Inc

Sterile and Packaging Operations Technician Level 1 ( MERCUSR143513ENUS)

Aerospace and Aviation

Operations

Yearly

No

West Point, Pennsylvania, United States

Job Description

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 connected to our global manufacturing network to ensure the highest quality of raw materials, intermediates and finished products.

The Senior Maintenance Technician is accountable for performing all preventative and corrective maintenance support for formulation, primary filling, inspection, and/or packaging equipment within their area of assignment for the start-up vaccine manufacturing facility at the Wilson, NC Site. This position will also be accountable for providing shop floor operations and environmental monitoring support to their area of assignment. This position will be an individual contributor and member of the Operations team within the Vaccines integrated process team.

This will be a hybrid role focused on startup and future routine operation of the pod vaccine manufacturing facility. The role will be accountable for ensuring that Environmental Health and Safety and GMP compliance is maintained for their area of assignment.

This role will also be accountable for troubleshooting and problem-solving equipment related issues and ensuring 100% PM compliance within their area of assignment.

Responsibilities

Delivery

  • Set up, adjust, repair, and maintain vaccines formulation, primary filling, inspection, and packaging equipment within the pod vaccine manufacturing facility

  • Execute and develop preventative maintenance for vaccine processing and packaging equipment

  • Conduct corrective maintenance and troubleshooting for vaccine processing and packaging equipment utilizing diagnostic equipment and programmable logic controllers as necessary

  • Partner with operators to execute manufacturing operations tasks within the pod vaccine manufacturing facility

  • Use technical information, drawings, diagrams, and schematics to aid in equipment maintenance troubleshooting and repairs

  • Disassemble and inspect parts and equipment to determine the cause of improper operation | Make repairs through the use of replacement parts and machine fabrications | Reassemble equipment with new or repaired parts

  • Minor and major overhauls to vaccine processing equipment by completely disassembling, repairing, and reassembling equipment to proper operation condition

  • Assemble and millwright functions in the receipt and installation of new equipment

Compliance

  • Accountable for performing work in a safe manner, following identified safety procedures (hazardous work permitting, and using applicable safety equipment/personnel protective equipment

  • Implement maintenance and operations functions in accordance with current Good Manufacturing Practices (cGMPs)

  • Complete documentation in batch record and/or computerized maintenance management system in accordance with site procedure

  • Maintain good housekeeping and 5S in assigned work area

  • Adhere to the highest level of data integrity while performing maintenance and operations duties

  • Ensure that work and adjustments performed within the pods is properly documented and executed in alignment with change management procedures

  • Assist in the investigation, root cause determination, and Corrective Action and Preventive Action implementation for equipment or personnel related compliance discrepancies noted during day to day activities and/or audits | Escalate as per IPT management processes

Cost

  • Participate in new equipment installations by interfacing with equipment vendors, recommending spare parts, selecting lubrication, assisting process-project engineers, assisting qualification, and performing initial de-bug for vaccines processing and packaging equipment

  • Ensure that startup activities for area of assignment are managed such that project deliverables and timelines are well defined in advance and met

  • Closely monitor equipment performance and improve reliability through problem solving and continuous improvement

  • Clean and lubricate equipment periodically and perform other maintenance work required to ensure efficient equipment operation

  • Determine proper equipment settings, clearances, and set-up standard work and respond effectively to equipment malfunctions to promote optimal productivity with minimal delays or discards

  • Recommend continuous improvement, productivity, and capital projects for the IPT

Team

  • Assist engineers and equipment vendors in new equipment installation including completion of qualification documentation

  • Provide technical and GMP guidance to outside contractors when they are performing work on process equipment

  • Act as liaison to the Utilities maintenance and Calibration teams

  • Maintain a culture of continuous improvement and focused on standard work, making problems visible, minimizing waste, reducing process variability, and problem solving

Education Requirements

  • High School diploma or equivalent and five (5) years of industrial maintenance experience or two (2) year technical degree with three (3) years of maintenance experience or equivalent

Experience and Skills

Required

  • Demonstrated industrial maintenance, mechanical, and electrical skills

  • Demonstrated ability to troubleshoot equipment utilizing a systematic approach to understand problems and determine appropriate solutions

  • Ability to read and understand electrical prints, P&IDs, and control loop diagrams

  • Demonstrated ability to work independently as team member

  • Ability to gown and work in an aseptic environment

  • Willing to work irregular hours to support multi-shift operation

Preferred

  • Maintenance experience within a vaccine, pharmaceutical, or GMP regulated environment

  • Aseptic filling, qualified inspection processes, systems, pharmaceutical packaging and serialization/aggregation

  • Working in a regulated environment (FDA, etc.) and basic knowledge of cGMPs as they apply to the vaccine/pharmaceutical industry

  • Continuous Improvement, Lean Manufacturing, Problem Solving, and Right First-Time methodologies

  • Systems Applications and Products / Manufacturing Execution System basic knowledge from either or production execution perspective

  • Working knowledge of machine shop equipment (lathe, drill press, grinder, milling equipment, welding, power cutting tools, etc.)

  • Ability to perform or support technical writing of documents such as preventive maintenance procedures (PMs) and standard operating procedures (SOPs)

  • Demonstrated ability and drive to work autonomously and help organize priorities and work for other team members

  • Outstanding communication skills both within direct team and across multiple shifts to ensure success of overall team

Our Manufacturing & Supply Division is dedicated to being the most trusted supplier of bio-pharmaceuticals 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.

VETJOBS

SKILLEDLABORUS

MSJR

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.

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

For more information about personal rights under Equal Employment Opportunity, visit:

EEOC Poster

EEOC GINA Supplement​

OFCCP EEO Supplement

Pay Transparency Nondiscrimination

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

Relocation:

No relocation

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

3rd - Night

Valid Driving License:

Hazardous Material(s):

Number of Openings:

1

Requisition ID:R143513