Maintenance/Calibration Manager

Job Description

The Maintenance/Calibration Manager is a leadership opportunity within the Engineering/Maintenance team supporting a new drug substance manufacturing operation. The individual in this role must provide direction, coaching, and technical expertise to maintenance and instrumentation technicians assigned to start up and maintain the new facility (process, utility and automation assets). This individual must actively manage his/her team to reliably support customer demand (including employee development, routine coaching sessions, recognition, and performance management). Additionally, the selected individual must become proficient in the use of manufacturing systems and knowledgeable of site procedures in order to resolve process/equipment issues, minimize downtime, and ensure product quality. This role actively supports, participates and embraces an inclusive team culture including significant interaction with Operations, Quality, Automation, Technology, and other groups as required.

Responsible for supporting:

• Process Equipment (e.g. tanks/bioreactors, filtration skids, chromatography columns)
• Support Equipment (e.g. washers, autoclaves, tube welders/sealers)
• Process Utility Systems (e.g. Clean-In-Place (CIP) Systems, Water for Injection (WFI), and Clean Steam (CS))
• Automated Systems (e.g. Distributed Control System (DCS), Programmable Logic Controllers (PLC), robotics)
• Maintenance Equipment (e.g. tools and calibration equipment)
• Act as an SME for maintenance operations

Employee Development / People Management:

• Hire, develop, motivate, and manage a team to ensure reliable maintenance/calibration execution.
• Assign yearly performance objectives and track metrics for the team in alignment with department and site goals
• Provide regular feedback and coaching to employees on work performance
• Provide leadership to the team as needed based on the team's capabilities and maturity
• Ensure on time approval of payroll activities using site approved software like ADP
• Ensure that training and certification are assigned and completed as expected

Quality & Safety Compliance:

• Foster strong safety culture on the team through actions, coaching, and prioritization
• Participate in safety/regulatory audits (i.e. tours, topic discussion)
• Coach individuals when reporting safety issues and completing corrective/preventative actions
• Drive culture of compliance through actions, consistent quality-driven decision making, and coaching of the team (e.g. documentation, housekeeping, area 5S, etc.)

Process Execution / 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
• Strong sponsor for the problem-solving efforts and solutions offered by other shifts and teams
• 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
• Actively lead the daily Tier 1 Process and participate in the Tier 2, as required
• Initiate SOP/PM/Calibration redlines and revisions
• Support planning of work to be scheduled
• Be in constant communication with Stakeholders to ensure no deviation from scheduled work.

Communication:

• Lead and support daily meetings to facilitate flow of information up/down through the organization
• Hold regular team meetings to cascade information and collect team feedback
• Provide clear consistent communication from shift to shift
• Escalate issues as needed to ensure the right support/awareness is given to issues as they arise
• Serve as a Subject Matter Expert during tours to provide area/process overview information to visitors/auditors upon request

Financial:

• 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

Education:

• Bachelor's degree in Business, Science, or Engineering with four (4) years of relevant experience in manufacturing/ military service OR
• High School Diploma/GED with six (6) years of relevant experience in manufacturing/military service

Required Experience and Skills:

• Demonstrated ability to lead a team (i.e. experience leading directly as a supervisor/coach or indirectly as part of a project or through routine process execution)
• Ability to manage multiple priorities and coordinate people/resources to meet schedule
• Strong interpersonal, communication, and problem-solving skills
• Travel required up to 30% of the time

Preferred Experience and Skills:

• 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
• CMRP, CRL or similar Maintenance certification
• 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
• Previous training individuals in complex manufacturing/work environments
• Meeting Facilitation/Training/Presentation Skills
• Planning, Implementing, Directing, Control, Decision Making

The manager must agree to work the following schedule:

• Regular schedule is 12-hour rotating day shift (2-2-3 day shift) aligned with the routine manufacturing schedule, which includes weekends and holidays.
• Flexibility to adjusting schedules may be required by the business needs.

#MSJR VETJOBS #EBRG TechnicianDurham

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

EEOC Know Your Rights

EEOC GINA Supplement

Pay Transparency Nondiscrimination

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.

Learn more about your rights, including under California, Colorado and other US State Acts

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:
25%

Flexible Work Arrangements:
Not Applicable

Shift:
1st - Day

Valid Driving License:
No

Hazardous Material(s):
N/A

Job Posting End Date:
01/31/2025
*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:R332057