Spclst, Engineering

Job Description

Senior Maintenance Specialist P2 Days

Primary Responsibilities

Reporting to the Associate Director of Maintenance and Engineering or the shift Maintenance Manager, the Maintenance Specialist primary responsibility will be to help facilitate day to day Maintenance and Metrology operations in support of DS4 manufacturing operations.

This role actively supports, participates, and embraces an inclusive team culture, including interaction with Operations, Quality, Automation, Technology, and other groups as required. The candidate will cover scheduled time off for managers as needed to ensure continuous operation and support. Furthermore, this role will help manage projects to drive improvements and efficiencies within the facility.

The Maintenance Specialist has the opportunity to develop into a manager with a rapidly growing pharmaceutical manufacturer

This position is an 8-hour shift position with the potential for infrequent off shift work as needed to support business results.

Primary activities for this position will include, but not be limited to:

• Assists the Maintenance manager in execution of duties
• Provide leadership to the Maintenance team including coaching, development, and performance management.
• Delivers operational improvements on key business projects, including updating weekly metrics and deliverables
• Promote a culture of continuous improvement and challenging the status quo
• Complete documentation of deviation events
• Review work order and calibration records for accuracy and proper documentation
• Support safety programs (LOTO, HECP, etc.) and environmental compliance from a maintenance perspective.
• Ownership of the Leader standardized work process which prioritizes resolution of issues from the shop floor
• Collaborate with peers to ensure a positive learning organization, alignment of strategy and sharing best practices
• Help develop training material, working as a subject matter expert (SME), and provide necessary training for system maintenance.
• Mentor others on effective communication and active listening techniques to fully understand needs and expectations
• Assist operations team and shop floor to with defining the requirements of the electronic batch record and successful execution
• Collaborates with the maintenance technicians and engineers to maintain all production equipment

Delivery

• Ensure that preventative and corrective maintenance support, as well as calibrations for Clean Utilities, Purification, Fermentation, Sterile Supply, and ALUM equipment, are performed according to the schedule and/or business needs.
• 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 metrics; ensures adherence to design standards and downtime tracking.
• Resolve and escalate issues impacting supply within the daily, weekly, and monthly IPT management processes.
• Actively lead the daily Tier 1 Process and participate in the Tier 2, as required
• Coach the team to ensure work orders and inventory transactions are complete, timely, and accurate
• Manage team staffing and overtime to support customer demand while meeting budget targets
• Recognize and communicate opportunities for cost savings

Compliance

• Ensure that maintenance activities are executed in compliance with Safety, Environmental and cGMP regulations.
• Ensure 100% PM compliance per maintenance schedule within team.
• Participate in internal and external audits and inspections.

Continuous Improvement

• Provide a leadership presence on the manufacturing floor
• Champion standard work to drive consistent use of best practices across teams
• Regularly help the team troubleshoot issues to minimize downtime and maintain product quality
• Represent maintenance and reliability input on project teams, as needed
• Subject Matter expert for LOTO and permit writing for maintenance activities, Safety Management Information Systems (SMIS) transactions
• Knowledge of mechanical/electrical maintenance and repair of mechanical, electrical and automated systems and equipment
• Support SOP/PM/Calibration redlines and revisions

Shift and Schedule

• The successful candidate will work a routine 8-hour weekday schedule. However, when covering vacations for other employees, the candidate will follow a 2-2-3, 12-hour day or night shift schedule, including holidays and alternating weekends. Additionally, the candidate will be required to support an on-call schedule for off-days and weekends to ensure continuous operation and support.

Minimum Required Education, Experience and Skills:

• Bachelor's degree or higher, preferably in Science or Engineering with two years (2) of relevant experience in manufacturing/military service

OR

• High School Diploma/GED with six years (6) of relevant experience in manufacturing/military service

Required Experience and Skills:

• Production/manufacturing experience, preferably in a cGMP environment required.
• Demonstrate ability to lead a team
• Maintenance experience; working maintenance knowledge of pharmaceutical processing, packaging, or utility equipment.
• 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.
• Must be willing and able to lift 50 lbs., bend, stoop, squat, crawl, twist, climb ladders, and wear a respirator.

Preferred Experience and Skills:

• Demonstrated record of successfully working in team environments and influencing people with a broad range of skills and experience.
• Performance mindset to drive and influence behaviors on the floor
• Self-motivation, ambition, resilience, and confidence in taking risk
• Ability to prioritize, focus on and obtain business results
• Excellent communication and organizational skills
• SAP, MES and DeltaV experience is an advantage
• CMRP, CRL or similar Maintenance certification
• Previous supervisory experience in a GMP-regulated manufacturing environment
• Safety focus in daily work
• Installation, operation, maintenance and/or troubleshooting experience with complex process and/or utility systems
• Experience using electronic manufacturing systems (e.g. BMS, MES, SAP, Delta-V, etc.)
• Experience in critical feedback and coaching, conflict resolution, performance management discussions
• Flexibility to perform various tasks to support the business.
• Lean, Six Sigma, KATA problem solving skills
• Ability to prioritize, align and simply to focus on and obtain business results

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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

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, 2nd - Evening

Valid Driving License:
Yes

Hazardous Material(s):
N/A

Required Skills:
Adaptability, Conflict Resolution, Deviation Investigations, Equipment Troubleshooting, Failure Mode and Effects Analysis FMEA, GMP Compliance, Identifying Customer Needs, Interpersonal Relationships, Maintenance Management, Microsoft Word, Pharmaceutical Processing, Regulatory Compliance, Reliability Management, Root Cause Analysis (RCA), Strategic Thinking, System Maintenance, Troubleshooting, Utility Systems

Preferred Skills:
Communication, Continuous Improvement, Interpersonal Communication, Leadership, Manufacturing, Manufacturing Operations, Meeting Organization, Motivating Teams, Prioritization, Scheduling

Job Posting End Date:
05/21/2025
*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.