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Associate Director, Engineering/Maintenance



Durham, NC, USA
Posted on Wednesday, June 5, 2024

Job Description

The Engineering, Maintenance and Site Services (EMSS) organization continuously strives to improve the reliability of the Durham site operations and provide the best-in-class services with the final goal of delivering our high-quality vaccines to the patients around the world with our core principle of Safety First and Quality Always.

The Associate Director, Engineering/Maintenance will support a new drug substance manufacturing operation’s engineering, maintenance, and calibration activities. This scope includes Sterile Supply, Fermentation, and Purification unit operations and associated clean utilities and process equipment. The Associate Director will manage tactical and strategic process, equipment, and qualification activities while ensuring product quality and optimized maintenance processes, regulatory compliance, employee and environmental safety, integration of new/existing technologies, customer service, resource utilization, financial performance and fiscal stewardship.


  • Demonstrates leadership and provides direction to individual contributors (professional employees) and/or managers of 24/7 shift teams supporting maintenance/calibration activities

  • Provides technical expertise in the development of predictive and preventive maintenance programs

  • Executes functional business plans and contributes to the development of group or company strategies

  • Prioritizes based on departmental budget and profit plan to address resource and operational challenges

  • Decisions are guided by company strategies and policies

  • Leverages relationships with key clients and/or customers to support business needs


  • Coaches/mentors direct reports accountable for their area within Engineering/Maintenance

  • Ensures proper team capabilities with appropriate training and project assignments

  • Manages the area succession plan


  • Assists Engineering & Maintenance Lead with managing the Engineering & Maintenance cost center, including capital spend, creating and managing all profit plans and forecasts throughout the year


  • Responsible for major equipment-related projects, including funding, change control and equipment qualification within their area

  • Responsible for obtaining bids, reviewing contracts, supervising, and providing follows-up on contract work including the auditing of time and material reports for their area


  • Responsible for assisting with master shutdown schedules and shutdown execution including all maintenance, calibration, capital project work, and GMP Cleaning coordination for all facility shutdowns

  • Coordinates with Durham Site Engineering and Technical CoE

  • Participates in daily shutdown meetings ensuring activities are tracked and completed


  • Responsible for developing maintenance and calibration strategies for utility/process equipment within operating area

  • Responsible for project management of operational readiness workstreams for new drug substance facility (i.e. maintenance master data, HECPs, SOPs)

  • Responsible for the daily support of all production equipment to ensure area safety, compliance, production and financial goals are met

  • Supports the reliability engineers periodic RBAM assessments and owns area specific reliability actions

  • Responsible for spare parts risk-based assessments and identification of new parts to replace obsolete parts to ensure correct type and number of spare parts are available for all production equipment.

  • Responsible for establishing processes that ensure required Safety guidelines are followed and participates in divisional Safety Audit activities

  • Reports Area monthly metrics and any action plans to address gaps

  • Identifies, prioritizes, and champions improvement projects to improve planned/unplanned downtime and overall equipment reliability

  • Assists in deviation investigations for maintenance instruments, equipment, and systems, as needed


  • Reports to Director, Engineering & Maintenance

  • Manages and interacts with employees within own department

  • Frequent interaction/partnership with employees from other departments (Operations, Technical, Automation, Quality)

  • Interacts with representatives from regulatory agencies

  • Interacts with external vendors/suppliers

Education Minimum Requirement:

  • Bachelor’s degree of science (BS) in Engineering, Science or related technical field with eight (8) years of progressive maintenance leadership experience in cGMP operations or in military positions listed; OR

  • Master’s degree of science (MS) in Engineering, Science or related technical field with six (6) years of progressive maintenance leadership experience in cGMP operations or in military positions listed; OR

  • PhD in Engineering, Science or related technical field with three (3) years of progressive maintenance leadership experience in cGMP operations or in military positions listed.

In association with educational requirement listed above, Military Service (US Navy, US Army, US Marine Corps, US Air Force, US Coast Guard) experience is required in the following functions or similar:

  • Maintenance Supervisor/Manager

  • Maintenance Planner and Scheduler

  • Reliability or Maintenance Engineering

  • Utilities Maintenance and Operations

Required Experience and Skills:

  • Minimum of 2 years of supervisory experience

  • Strong planning, scheduling, and time management skills

  • Working knowledge regulatory requirements in accordance with GMP manufacturing operations

  • Good oral and written communication skills

  • Project management, including change control and equipment qualification

Preferred Experience and Skills:

  • Experience with GMP compliant calibration and maintenance databases

  • SAP experience related to plant maintenance and spare parts procurement systems

  • Reliability engineering knowledge (including asset life cycle management) and CMRP certification

  • Asset condition monitoring experience using predictive maintenance tools such as vibration analysis, ultrasound, IR, etc.

  • Experience with formal problem-solving techniques, such as root cause analysis (RCA), failure mode effects analysis (FMEA), and/or Lean Six Sigma tools.

  • Working knowledge of current Good Manufacturing Practices(cGMP) experience in a sterile, bulk or finished pharmaceutical environment

  • Demonstrated experience of interacting with site, divisional or regulatory audits

  • Green Belt/Black Belt Certification


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.

Current Employees apply HERE

Current Contingent Workers apply HERE

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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:

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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:




VISA Sponsorship:


Travel Requirements:


Flexible Work Arrangements:

Not Applicable


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Job Posting End Date:


*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.

Job Posting End Date:06/19/2024

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:R298335