Job Description

Seeking candidates for a Senior Specialist position within our Company's research laboratories Biologics Pilot Plant (BPP) Equipment Engineering Team. In this individual-contributor role you will lead complex equipment engineering, maintenance strategy, and operational support for pilot-scale GMP manufacturing equipment.

Key Responsibilities

• Act as technical owner for multiple designated equipment systems—drive lifecycle management including maintenance strategy, spare parts optimization, and obsolescence planning.

• Lead and prioritize corrective maintenance, calibrations, preventative maintenance, and spare parts inventories for assigned equipment to ensure readiness for GMP campaigns.

• Lead Lock Out / Tag Out, isolation, and other equipment safety procedures; lead root-cause investigations and corrective actions for equipment upsets and events.

• Author, review, and approve change management documentation (Change Controls, CAPAs, QNs) and provide technical justification where required.

• Lead small- to medium-scale capital projects from concept through handover (scope, design input, vendor selection, commissioning, and documentation); act as primary liaison with project engineering, procurement, and construction teams.

• Evaluate, pilot, and recommend new technologies, equipment, and process improvements to enhance throughput, reliability, or compliance.

• Ensure engineering activities meet regulatory and company safety expectations.

• Coach and mentor junior engineers; provide technical leadership in multidisciplinary teams and during off-hour manufacturing support as needed.

• Support audit readiness and respond to regulatory inquiries related to equipment.

An understanding of the regulatory guidelines governing GMP operations is important. Candidate is expected to work in a team atmosphere in close collaboration with plant personnel, EM&U, Quality, environmental, and safety groups. Occasionally supporting off-hour manufacturing may be required.

Education Minimum Requirement:

• Bachelor’s degree in engineering with 5 years’ experience required, or a master’s degree with 3 years’ experience. Candidates with a bachelor’s degree in a non-technical discipline plus substantial relevant experience in pharmaceutical/biologics equipment management will be considered in lieu of a formal engineering degree.

Required Experience and Skills:

• Demonstrated experience supporting equipment and/or GMP manufacturing facilities, preferably in biologics or vaccine production.

• Deep working knowledge of cGMP, Quality Systems, and equipment safety requirements as applied to pilot-scale GMP operations.

• Proven experience writing/reviewing technical documentation (protocols, reports, change controls, SOPs).

• Strong problem-solving skills with experience performing root-cause investigations and driving corrective actions.

• Excellent interpersonal skills with demonstrated ability to work effectively in matrixed, cross-functional teams.

• Self-motivated, able to operate independently and prioritize in a fast-paced, dynamic environment.

• Willingness to support off-hour manufacturing and occasional overtime/weekend coverage.

Preferred Experience and Skills:

• Track record leading capital projects and technical evaluations of new equipment or technologies in a regulated environment.

• Strong project management skills, including scope definition, vendor management, schedule control, and budget awareness.

• Hands-on technical knowledge of pharmaceutical production equipment (fermenters/bioreactors, CIP/SIP systems, filtration/skid-based equipment) and automation controls.

• Experience mentoring staff and driving continuous improvement initiatives.

Required Skills:

Adaptability, Adaptability, Analytical Testing, Capital Projects, Corrective Maintenance, Data Analysis, Detail-Oriented, Deviation Management, Equipment Qualification, GMP Compliance, Good Manufacturing Practices (GMP), Machinery Safety, Maintenance Strategy, Manufacturing Automation, Process Design, Process Hazard Analysis (PHA), Process Optimization, Project Engineering, Project Management, Regulatory Compliance, Root Cause Analysis (RCA), Strategic Thinking, Technical Leadership, Technical Problem-Solving, Technical Writing {+ 2 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

$117,000.00 - $184,200.00

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:

No relocation

VISA Sponsorship:

No

Travel Requirements:

10%

Flexible Work Arrangements:

Not Applicable

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

N/A

Job Posting End Date:

04/24/2026

*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.

Requisition ID:R393652