Job Information
Merck Manager, Vaccine Operations and Maintenance in Wilson, North Carolina
Job Description
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 Manager, Operations and Maintenance position serves as the first-line leader for day to day maintenance and operations activities within the vaccine manufacturing facility at the Wilson, NC Site. This position will generally be responsible for a single shift of operation and be a member of the Operations team within the vaccine manufacturing integrated process team (IPT).
The Manager, Operations and Maintenance will be responsible for building a maintenance and operations team to support start up, licensure, and continuing operations for the vaccine manufacturing facility at the Wilson site. The position is responsible for providing day to day tactical direction to the vaccine manufacturing Operations and Maintenance team, ensuring that business objectives are met within budgetary constraints and that a high standard for Quality and EHS compliance is maintained. The position will also be expected to promote behaviors of continuous improvement (aligned with MPS principles) and ensure that the Operations and Maintenance team maintains an inclusive culture that supports positive employee relations.
Primary activities for this position will include, but not be limited to:
Delivery
Utilize a high degree of independent judgment and decision-making to direct vaccine manufacturing, packaging, maintenance, and support personnel to ensure manufacturing schedules and customer supply requirements are achieved.
Ensure that preventative and corrective maintenance support to CIP/SIP, primary filling, inspection, and/or packaging equipment is performed per schedule and/or business need.
Provide equipment related expertise and technical guidance necessary to troubleshoot and problem-solve equipment related issues to minimize impact to supply.
Manage adherence to departmental maintenance and operational metrics; ensures adherence to design standards and downtime tracking.
Resolve and escalate issues impacting supply within the daily, weekly, and monthly IPT management processes.
Compliance
Ensure that vaccine manufacturing operations are executed in compliance with Safety, Environmental, cGMP, and Labor regulations.
Investigate, determine root cause, and implement robust CAPAs for any team related compliance discrepancies noted during day to day activities and/or audits. Escalate as per IPT management processes.
Ensure 100% PM compliance per maintenance schedule within team.
Provide business owner review and approval for IQ/OQ/PQ, SOPs, validation, and change control documentation.
Participate in internal and external audits and inspections.
People Management / Leadership
Assist team with development of objectives and ensure alignment with site goals.
Staff shop floor maintenance and operations positions necessary to execute multi-shift vaccine aseptic filling, inspection, and packaging at the Wilson site.
Provide leadership to the Operations and Maintenance team including coaching, development, and performance management.
Ensure a culture of inclusion and consistency is maintained, supporting positive employee relations at the shop floor level within the team and site.
Provide mentorship and training to team and peers.
Liaison effectively with alternate shifts, site Maintenance & Utilities, and Reliability Engineering teams to share best practices, deliver training, and ensure consistency and alignment in approach.
Actively participate on cross-functional teams in an inclusive manner to advance project goals and achieve deliverables.
Cost
Ensure that vaccine manufacturing IPT maintenance and operations are carried out in accordance with departmental budget.
Recognize and implement opportunities for efficiency and financial savings.
Provides shop floor related input to departmental budget and recommends continuous improvement opportunities and capital projects for the IPT.
Continuous Improvement
Partner with Technology, Quality, and other groups to identify and implement continuous improvement initiatives that support the strategic goals of the vaccine manufacturing IPT.
Embed a culture of continuous improvement and MPS into the Operations team focused on standard work, making problems visible, minimizing waste, reducing process variability, and problem solving.
Identify opportunities to modify standard work, procedures, or equipment to optimize efficiency.
This position will regularly be working day shift 12 hours, 3 days one week and 4 days the next week. Must be willing to work irregular hours/days to support multi-shift operation on an as needed basis.
Education Minimum Requirement:
- High School diploma or equivalent (BS degree in Science or Engineering field preferred)
Required Experience and Skills:
Minimum 5 years production/manufacturing experience, preferably in a cGMP environment
Minimum 2 years coaching/supervisory experience, preferably in a cGMP manufacturing or packaging environment
Demonstrated electro-mechanical troubleshooting and problem-solving skills with an understanding of maintenance processes, common equipment, and Computerized Maintenance Management Systems.
Demonstrated ability to work independently as a team leader and team member.
Demonstrated ability to motivate teams to achieve stretch goals and manage multiple priorities.
Demonstrated strong leadership and interpersonal skills with ability to coach, influence and support others through a culture of inclusion, feedback and empowerment.
Working knowledge of cGMPs and of regulatory requirements as they apply to the vaccine/pharmaceutical industry.
Ability to read and understand technical documents, drawings and specifications.
Proficiency using standard software including MS Excel, MS Word, etc.
Willing to work irregular hours to support multi-shift operation on an as needed basis.
Strong written and verbal communication skills including technical writing experience with investigations, job plans, change requests, standard operating procedures, batch records, protocols, etc.
Preferred Experience and Skills:
BS degree, preferably with emphasis in Science or Engineering field.
Experience with aseptic filling, qualified inspection processes, CIP/SIP systems, pharmaceutical packaging, and/or serialization/aggregation.
Maintenance experience; working maintenance knowledge of pharmaceutical processing, packaging, or utility equipment.
Strong experience utilizing CMMS 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.
Experience in Continuous Improvement, Lean Manufacturing, Problem Solving, and/or Right First Time methodologies.
Familiarity with Change Execution Management and Behavioral Coaching / Consequence Management tools.
SAP / MES working knowledge.
Experience supporting regulatory inspections including FDA.
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.
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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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, generally Tuesday, Wednesday and either Monday or 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”.
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:
Regular
Relocation:
Domestic
VISA Sponsorship:
No
Travel Requirements:
10%
Flexible Work Arrangements:
Not Applicable
Shift:
1st - Day
Valid Driving License:
No
Hazardous Material(s):
N/A
Requisition ID: R290976