Job Description

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:

Delivery

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.

Compliance

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.

Cost

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

Team

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

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U.S. Hybrid Work Model

Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.

San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance

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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:

Regular

Relocation:

Domestic

VISA Sponsorship:

No

Travel Requirements:

No Travel Required

Flexible Work Arrangements:

Not Applicable

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

N/A

Job Posting End Date:

11/27/2024

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID:R321800