Job Description
Job Description Position Overview - Essential Functions The Manager, Operations and Maintenance position (3rd shift) 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
Primary Activities include, but are not 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 third shift. 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 strongly 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.
Reporting Relationships: - Solid line report to: Associate Director, RotaTeq® Operations-------
- Dotted line report to: N/A
- Position(s) reporting to this position: Maintenance and Operations Technicians (for assigned shift)
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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".
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Employee Status: Regular
Relocation: Domestic
VISA Sponsorship: No
Travel Requirements: 10%
Flexible Work Arrangements: Not Applicable
Shift: 3rd - Night
Valid Driving License: No
Hazardous Material(s): n/a
Job Posting End Date: 04/16/2025
*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: R342990
Job Tags
Full time, Local area, Remote job, Relocation, Visa sponsorship, Flexible hours, Shift work, Night shift, 3 days per week,