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Job Description

**The Associate Director of Engineering and Maintenance** serves as the site engineering lead for the startup of a pharmaceutical filling and lyophilization facility. This position has a broad range of responsibilities with opportunities to grow and develop to higher levels of management within our company's Animal Health organization.

Specifically, the Associate Director will partner with our Global Engineering team to build and lead the commissioning, qualification, and validation of a new pharmaceutical filling and lyophilization facility. This role will ensure compliance with USDA, and industry regulations while overseeing the successful startup of aseptic manufacturing operations, including vial filling and freeze-drying processes. Significantly, this individual will build and manage an engineering team capable of supporting long-term operations.

Responsibilities:

+ Serve as site engineering lead within a start up filling and lyophilization facility.

+ Provide leadership and vision for the startup site Engineering and Maintenance teams during construction, commissioning and qualification of the facility.

+ Lead the commissioning and qualification of pharmaceutical filling and lyophilization equipment, clean utilities, and facility systems.

+ Manage Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT) for critical equipment.

+ Troubleshoot and optimize equipment performance during startup.

+ Work closely with internal stakeholders, equipment vendors, and contractors to ensure timely and compliant startup.

+ Recruit, hire, and train a high-performing engineering team to support facility startup and ongoing operations.

+ Define roles and responsibilities for key engineering functions, including maintenance, , utilities, and process engineering.

+ Provide leadership, mentorship, and professional development for engineering staff.

+ Develop a robust preventive maintenance and reliability engineering program to ensure long-term facility performance.

+ Collaborate with manufacturing, quality, and regulatory teams to align validation strategies with business goals.

+ Develop and maintain project timelines, ensuring key milestones are met.

+ Ensure compliance with data integrity and automation best practices.

+ Support regulatory audits and inspections, addressing CQV and engineering-related queries.

+ Additional duties as assigned

Minimum education required:

+ Bachelor’s degree in engineering

+ MBA or master’s degree in Engineering preferred.

Required Experience and Skills:

+ 8-10 years of relevant experience with Construction, Plant engineering and/or Manufacturing environments.

+ Possess flexible leadership skills with an ability to staff and lead Engineering Teams.

+ Must have experience with Capital Construction projects and People Management experience

+ Prior experience with Project Management and Financial execution

+ Experience in a USDA or FDA manufacturing environment

+ Ability to communicate effectively with all levels of the organization on site and above site management.

+ Proven project and construction management capabilities

+ Good equipment / process trouble shooting skills.

**Preferred Experience and Skills** :

+ Biotechnology manufacturing / sterile processing and lyophilisation experience

+ Knowledge / experience with process validation (URS, FRS, IOQ, PQ)

+ Knowledge of automation (SCADA, BMS, PLCs, DCS)

+ Good understanding of mechanical, electrical, and plumbing (MEP) system design

+ Proficient in using PC applications, including Microsoft Office Suite (Outlook, Excel, Word, Project) and Adobe.

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Current Employees apply HERE (https://wd5.myworkday.com/msd/d/task/1422$6687.htmld)

Current Contingent Workers apply HERE (https://wd5.myworkday.com/msd/d/task/1422$4020.htmld)

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 (https://survey.sogosurvey.com/r/aCdfqL) 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:

EEOC Know Your Rights (https://www.eeoc.gov/sites/default/files/2022-10/22-088\_EEOC\_KnowYourRights\_10\_20.pdf)

EEOC GINA Supplement​

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 (https://www.msdprivacy.com/us/en/CCPA-notice/)

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:

Not Indicated

Valid Driving License:

Yes

Hazardous Material(s):

N/A

Job Posting End Date:

05/24/2025

*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:** R346916