Our Engineers support internal and external manufacturing operations remain operational, continuously improve and innovate. With our extensive range of facilities and environments, our Engineers have opportunities across many diverse areas including Biological, Chemical, Automation, Capital Projects, Maintenance, Safety, Process Development, Technical Services, Utilities and Validation.
The Specialist, Vaccines Reliability Engineer position is responsible for providing reliability maintenance engineering support to the start-up pod vaccine manufacturing facility at the Wilson, NC Site. This position will be an individual contributor and member of the Operations team within the Vaccines Integrated Process Team.
This role will own the reliability performance for the pod vaccine manufacturing facility and be responsible for building the reliability program, computerized maintenance management system structure, and developing and calibration plans needed to support the startup. In addition, this position will be responsible for tracking reliability related metrics and ensuring optimum equipment performance during the transition to routine commercial operation. Primary activities for this position will include, but not be limited to:
- Utilize technical expertise, experience, independent judgment, and decision-making to build a robust maintenance and reliability program that supports consistent and reliable supply.
- Responsible for PM and calibration program development, changes and optimization to include task lists for calibrations, linked equipment classification characteristics for internal Systems Applications and Products calibrations
- Participate in Factory Acceptance Testing for new and modified equipment installations
- Responsible for spare part data additions for new or existing equipment, changes and deletions to Bill Of Materials (equipment, functional location), Task List (required components)
- Maintain and analyze equipment data & historical records to help anticipate maintenance needs and trends; Analyze equipment & maintenance performance
- Maintain equipment data, PM and calibration plans and coordinate the calibration program within the business unit. Develops equipment specific training outlines and develops and tracks metrics.
- Provide secondary support for maintenance or reliability issues impacting supply within the daily, weekly, and monthly IPT management processes.
- Develop and provide ongoing ownership for safety instructions and SOPs for maintenance including Hazardous Energy Control Procedure for the pod vaccine manufacturing facility
- Initiate & process maintenance change controls for equipment, PM and calibration program optimizations
- Support process change controls related to equipment changes (evaluation, approval, communication, planning scheduling, qualification, project documentation, auditing, training, implementation)
- Partner with Maintenance & Utilities team to manage Critical Calibration Out of Tolerance reporting
- Act as maintenance subject matter expert during regulatory inspections
- Investigate, determine root cause, and implement robust Corrective Action and Preventive Actions for any equipment related compliance discrepancies noted during day to day activities and/or audits. Escalate as per IPT management processes.
- Ensure that Maintenance related startup activities for the pod vaccine manufacturing facility are managed such that project deliverables and timelines are well defined in advance and met.
- Identify and apply creative/technical solutions aimed at cost reduction, reduced scrap, and quality of products and/or facilities which meet all regulatory requirements
- Apply technical skills and problem solving to correct equipment related issues that result in production downtime or consume excessive maintenance resources
- Recommend continuous improvement, productivity, and capital projects for the IPT.
- Manage small capital reliability projects including analysis, design, planning, scheduling, securing funds, coordinating equipment, procurement, cost control, supervising contracted resources, status reporting, communication, ensuring team involvement
- Assist in designing & monitoring an effective and economical system driven towards Reliability Centered Maintenance
- Liaison effectively with site Maintenance & Utilities and Reliability Engineering teams to share best practices, deliver training, and ensure consistency and alignment in approach.
- Partner with Operations, Quality, and other groups to execute projects that support the strategic goals of the Vaccines IPT.
- Ensure all equipment manuals are updated and adequate to support the maintenance team
- Maintain a culture of continuous improvement and focused on standard work, making problems visible, minimizing waste, reducing process variability, and problem solving.
- Actively participate on cross-functional teams in an inclusive manner to advance projects goals and achieve deliverables.
Education Minimum Requirement:
- High School diploma or equivalent (AS or BS degree in Science or Engineering field preferred) with minimum 3 years of maintenance experience
Required Experience and Skills:
- Minimum 3 years of relevant industrial maintenance and/or equipment reliability work experience
- Working maintenance knowledge of pharmaceutical processing, packaging, or utility equipment
- Demonstrated ability to work independently and as team member
- Demonstrated strong interpersonal skills with ability to influence and support others through a culture of inclusion, feedback, and empowerment
- Strong experience utilizing systems (SAP, etc.), maintenance work management processes, performance monitoring tools, maintenance/calibration related paperwork, process control computer applications, project management practices, and expense and financial systems.
- Working knowledge of regulatory requirements in including safety, environmental, and cGMP as they apply to the vaccine/pharmaceutical industry
- Experience working in a regulated environment (i.e. FDA)
- Willing to work irregular hours to support multi-shift operation on an as needed basis
Preferred Experience and Skills:
- Experience with aseptic filling, qualified inspection processes, pharmaceutical packaging, and serialization/aggregation.
- Experience leading manufacturing / packaging projects and investigations
- Experience in Continuous Improvement, Lean Manufacturing, Problem Solving, and/or Right First-Time methodologies
- Familiarity with Change Execution Management tools
- Technical writing experience with investigations, job plans, change requests, standard operating procedures, batch records, protocols, etc. including proficiency using standard software including MS Excel, MS Word, etc.
- Experience supporting regulatory inspections including FDA
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 …
Merck & Co., Inc., Kenilworth, New Jersey, USA is known as “Merck” in the United States, Canada & Puerto Rico. We are known as “MSD” in Europe, Middle East, Africa, Latin America & Asia Pacific. We are a global biopharmaceutical leader with a diverse portfolio of prescription medicines, oncology, vaccines and animal health products.
We are driven by our purpose to develop and deliver innovative products that save and improve lives. With 69,000 employees operating in more than 140 countries, we offer state of the art laboratories, plants and offices that are designed to Inspire our employees as we learn, develop and grow in our careers. We are proud of our 125 years of service to humanity and continue to be one of the world’s biggest investors in Research & Development.
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