Job Description

The Biologics Process Research & Development organization within our Company Research Labs is responsible for developing the drug substance manufacturing processes for our Company's biologics pipeline. We work closely with colleagues in Discovery, Pre-clinical, and Early Development to rapidly develop processes for diverse biotherapeutics and efficiently produce material to supply clinical trials. We are also responsible for commercial process development, and development and implementation of new technologies. We work with our partners in our Company Manufacturing Division to commercialize and launch new products.

This role will support the Next Generation Biologics (NGB) facility, which will be a premier, state-of-the-art facility, that is a key part of our Chemistry, Manufacturing, and Controls (CMC) hub at our site headquarters in Rahway, NJ. This facility will be fully online in the next few years, both in terms of facility construction and organizational realization. The GMP facility is designed for multi-product operations with flexible operating suites, which can adjust as the clinical pipeline demands change. It can meet all historic, currently existing, and cutting-edge biologics program demands from supporting development to pilot, small- and large-scale potent material handling, and the ability to integrate new technologies and cell-line platforms.

The Facility & Utilities Engineering Lead will be a member of the Engineering & Automation leadership team and will report to the Head of Engineering & Automation for NGB.

Job Responsibilities:

• Lead the Facility & Utilities Engineering team to ensure 24/7/ 365 building support for critical GMP operations.

• Manage process & facilities equipment, and utilities (clean and grey) maintenance and calibration.

• Maintain redundancy through training for operation, metrology, maintenance, etc. to provide off-hours, weekends and holidays coverage.

• Ensure areas of accountability are delivered in accordance with EHS regulatory and company EHS requirements.

• Build robust communication channels with site support teams (utilities, etc.) and NGB operations to coordinate planned and unplanned activities, annual shutdowns to maintain robust building operations.

• Manage and provide oversight to outsource service providers, such as equipment service providers, GMP area cleaning, etc.

• Drive continuous improvement programme across all areas – safety, environmental management, quality compliance, equipment reliability and uptime, efficiency and operational excellence.

• Manage a team, which includes hiring and building team capabilities and performance management to meet the operational requirements of the facility as well as provide leadership and personnel development strategies.

• Support facility and utilities assessment for New Product Introduction, as required.

• Support Energy Management, Environmental Sustainability & Business Continuity activities through data.

• Accountable for delivery of Engineering spend within approved budget.

• Investigate equipment failures or area deviations to find root cause and implement effective Corrective and Preventative Actions (CAPA).

• Conduct life cycle analysis of all critical system equipment to ensure equipment is upgraded and replaced in accordance with the Site Master Plan.

• Serve as a technical mentor and help train rotational and new employees, and supervise staff performing GMP activities and deliver training as needed.

Required Education, Experience and Skills:

Education:

Bachelor’s degree in chemical/biochemical engineering, pharmaceutical sciences, chemistry, biochemistry, biology, microbiology, or related discipline with minimum of 8 years relevant experience, or a Master’s degree with minimum 6 years of relevant experience.

Experience & Skills:

• Demonstrated experience (8 years minimum) in a GMP-regulated biological drug substance manufacturing environment, ideally with experience of single-use systems.

• Prior experience of team management and monitoring performance

• Possess a deep understanding of a facilities and engineering management in GMP (Good Manufacturing Practice) environment with detailed knowledge and experience of clean utilities systems.

• Strong working knowledge of cGMP, Quality Systems (problem, deviations, change management, etc.), Safety for operations.

• Ability to perform technical analysis to drive continuous improvement and overall efficiency.

Preferred Experience and Skills:

• Culture Building: Establish a high-performance culture that promotes innovation, diversity, and inclusion within the team

• Track record of working effectively with team-members of diverse skill sets and backgrounds

• Excellent troubleshooting and problem-solving skills and the ability to overcome technical and organizational challenges

• Delta V and MES (Manufacturing Execution System) knowledge and experience

• Strong verbal and written communication skills, and attention to detail

• Experienced in the administration of GMPs, Good Documentation Practices (GDPs), and S&E regulations as it pertains to engineering.

• Proven self-motivation, ability to drive improvements, and inspire others.

• Demonstrated ability to work effectively as part of diverse teams.

• Ability to challenge the status quo with a continuous improvement mindset.

• Strong leadership ability and collaborative skills.

• Strong analytical and presentation skills.

• Ability to lift 25 lbs, if required.

#PRD

Required Skills:

API Manufacturing, API Manufacturing, Applied Engineering, Business Continuity, Change Control Systems, Chemical Process Development, Clinical Trials, Cross-Cultural Awareness, Cross-Functional Teamwork, Employee Development, Equipment Qualification, Facility Management, GMP Compliance, Immunochemistry, Leadership, Management Process, Manufacturing Processes, Manufacturing Process Validation, Microbiology, Operational Excellence, People Leadership, Pharmaceutical Sciences, Process Optimization, Regulatory Inspections, Regulatory Requirements {+ 4 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:

EEOC Know Your Rights

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

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

$139,600.00 - $219,700.00

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:

No Travel Required

Flexible Work Arrangements:

Not Applicable

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

n/a

Job Posting End Date:

01/31/2026

*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.