Job Description

The Associate Director, Maintenance provides operational leadership and technical oversight of maintenance activities for the sterile product manufacturing site. In this role, the Associate Director ensures equipment reliability, safe work practices, and regulatory compliance while supporting production needs and continuous improvement initiatives.

In addition, this role will support the development and execution of the site’s Integrated Facilities Management (IFM) strategy and will actively participate throughout the project life cycle in Factory Acceptance Tests (FATs) for utilities, facilities, and process equipment to ensure maintainability, reliability, and lifecycle considerations are incorporated into equipment and system design.

Key Responsibilities

- Capital Projects & Equipment Lifecycle Support

- Participate as the maintenance representative in major capital project design, execution, and start-up, with primary emphasis on start-up readiness—ensuring maintenance strategies, CMMS build-out, spare parts, diagnostic capabilities, SOPs, training, and reliable systems turnover are fully in place prior to qualification and initial manufacturing—along with participation in future capital equipment installations and small- to mid-scale upgrade projects, coordinating contractors and internal resources under engineering or project management leadership.

- Attend and actively participate in utility, facility, and process equipment Factory Acceptance Tests (FATs) throughout the project life cycle.

- Provide maintenance and reliability input during FATs to ensure:

• Maintainability and accessibility are considered
• Spare parts strategies are optimized
• Standardization, diagnostics, and serviceability are aligned with site practices

- Support equipment turnover to maintenance, including documentation review, CMMS asset setup, and maintenance strategy development.

Maintenance Operations & Leadership

• Oversee day-to-day maintenance operations for assigned production areas, including preventive, predictive, and corrective maintenance activities.
• Supervise, coach, and develop maintenance staff; ensure adherence to safe work practices and OSHA/GMP requirements.
• Coordinate maintenance priorities with production, quality, and engineering teams to minimize downtime and support production schedules.
• Ensure accurate and timely execution and documentation of maintenance activities within the CMMS.
• Maintain key maintenance performance metrics for assigned areas and communicate operational status to site leadership.

Integrated Facilities Management (IFM) Support

• Support the development, deployment, and ongoing execution of the site IFM strategy in alignment with site leadership objectives.
• Serve as a key maintenance interface with IFM service providers, ensuring alignment with maintenance standards, safety expectations, and GMP requirements.
• Participate in defining maintenance scopes of work, service-level expectations, and performance metrics related to IFM services.
• Support monitoring of IFM performance and identification of continuous improvement opportunities at the operational level.

Reliability & Continuous Improvement

• Implement and sustain preventive and predictive maintenance tasks as defined by site strategy and reliability programs.
• Support troubleshooting and root-cause analysis for major equipment or system failures; coordinate corrective actions with engineering and subject-matter experts.
• Apply Lean and continuous improvement principles at the area or equipment level to reduce downtime and improve maintenance efficiency.
• Support reliability improvement initiatives by providing operational insights on equipment performance and maintainability.

Compliance & Regulatory Readiness

• Ensure all maintenance activities comply with GMP requirements, safety regulations, and site procedures.
• Prepare, maintain, and provide maintenance records and documentation to support internal reviews and regulatory inspections.
• Support inspection readiness activities by ensuring assigned areas meet compliance and documentation expectations.

Qualifications

Required

• Bachelor’s degree in Engineering, Facilities Management, or a related technical field with
• Seven (7) years of maintenance experience in pharmaceutical or biotech manufacturing; sterile manufacturing experience strongly preferred.
• At least three (3) years in a supervisory or team-lead role with responsibility for maintenance technicians or supervisors.
• Practical experience with CMMS, preventive maintenance, and predictive maintenance programs.
• Familiarity with GMP, safety regulations, and industry standards applicable to sterile manufacturing.
• Proven experience troubleshooting process equipment and coordinating corrective actions with cross-functional teams.
• Working knowledge of Lean principles or continuous improvement methods.
• Strong communication skills and ability to collaborate across production, quality, engineering, and facilities teams.

Preferred

• Experience with potent compound manufacturing
• Experience supporting or interfacing with Integrated Facilities Management (IFM) organizations.
• Experience participating in or supporting FATs, SATs, and equipment qualification activities.
• Exposure to predictive maintenance technologies (vibration analysis, ultrasound, thermography) or coordination with Predictive Maintenance (PdM) service providers.
• Demonstrated ability to develop, coach, and retain maintenance technicians.

Required Skills:

Adaptability, Adaptability, Capital Projects, Computerized Maintenance Management Systems (CMMS), Corrective Action Management, Corrective Maintenance, Digital Transformation, Documentation Review, Driving Continuous Improvement, Facility Management, GMP Compliance, HVAC Systems, Maintenance Documentation, Maintenance Management, Maintenance Strategy, Occupational Health and Safety Management, People Leadership, Predictive Maintenance, Preventative Maintenance Programs, Preventive Action, Process Control Systems, Regulatory Compliance, Reliability Engineering, Safety Leadership, Technical Writing {+ 1 more}

Preferred Skills:

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.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

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We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills 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”.

The salary range for this role is

$142,400.00 - $224,100.00

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.

You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

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

Valid Driving License:

No

Hazardous Material(s):

N/A

Job Posting End Date:

05/2/2026

*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.