Job Description

A compelling opportunity has arisen for a Process and Technical Engineering Lead to provide technical leadership across a diverse biologics portfolio, spanning multiproduct clinical and commercial manufacturing facilities. Reporting to the Global Head of Biologics Technical Operations, this role is accountable for driving technical rigor and excellence from a facility‑fit and process engineering perspective, enabling right‑first‑time execution as processes are transferred across the internal and external manufacturing network, while also supporting ongoing commercial manufacture.

The role combines strategic oversight with hands‑on technical leadership across biologics drug substance (DS) manufacturing, with responsibility across multiple facilities and suites. A strong understanding of the interplay between automation, process, equipment, and facility design is central to success in this position.

Key Responsibilities

Technical Leadership & Facility Fit

Provide end‑to‑end technical leadership for facility‑fit assessments for both inline and New Product Introduction (NPI) programs, ensuring robust evaluation of process–equipment–facility interfaces.
Lead the identification, prioritization, and resolution of engineering issues arising during facility‑fit activities and execution readiness, including support to batch‑related activities as required.
Deliver strong technical oversight to ensure technical excellence and right‑first‑time execution during process transfers into the internal and external manufacturing network.

Process & Equipment Expertise

Act as a subject matter expert (SME) in biologics process equipment, maintaining deep knowledge of equipment capabilities and limitations across multiple facilities.
Serve as an SME in the development of digital twin solutions and strategic improvements to support facility‑fit activities. Make recommendations for site equipment investments to enable readiness for future‑state molecules and platforms, and define KPIs that measure facility‑fit success and drive continuous improvement.
Provide technical input to upstream and downstream platform definitions, based on expert understanding of facility capabilities and the interface between manufacturing processes and equipment.
Collaborate closely with broader Science & Technology (S&T) functions to share expertise, build capability, and upskill teams on process and equipment understanding.

Team Leadership & Capability Building

Establish and lead a small, focused team of engineers who serve as dedicated experts in processes and process equipment across the manufacturing network.
Cultivate a culture of technical excellence, collaboration, and innovation, enabling cross‑functional learning and standard methodology sharing.
Develop, mentor, and coach engineering team members to build a strong and sustainable talent pipeline.
Partner with Technical Operations and receiving‑unit teams to drive New Product Introduction and Technology Transfer activities, ensuring a deep understanding of the interconnectivity between operations, process, and equipment.

Who You Are

You are ready for this role if you have the following:

B.S., M.S., or Ph.D. in a relevant Engineering or Science discipline.
A minimum of 9 years’ experience in biopharmaceutical manufacturing and/or development, with a strong emphasis on scientific and technical roles.
Demonstrated technical excellence with deep understanding of biologics molecules, manufacturing processes, process equipment, and automation.
Experience in biologics drug substance development, technical operations, and new product introduction.
Strong cross‑divisional networking and collaboration skills.
Experience working within technical operations at a manufacturing site.
Experience with regulatory filings, quality notifications, investigations, and CAPA management.
Proven leadership with the ability to influence at all organizational levels.
Strong talent‑building capabilities, with both strategic and detail‑oriented strengths.
Solid understanding of product management systems, business and financial principles, and the ability to manage multiple programs simultaneously.
A strong sense of urgency, motivational leadership style, and agility in driving change.

Our Dunboyne facility joined our network in September 2020 and is our first Biologics Drug Substance single‑use commercialisation site. It plays a critical role in bringing innovative medicines to market, driven by cutting‑edge technology and close collaboration between research and manufacturing teams to deliver meaningful impact for patients worldwide.

Required Skills:

Biopharmaceuticals, Change Management, Cross-Functional Leadership, Engineering Process Management, GMP Operations, Manufacturing Systems, New Product Introduction (NPI), People Leadership, Technical Leadership, Technical Operations

Preferred Skills:

Business Strategy Planning, Lean Six Sigma (LSS)

Current Employees apply HERE

Current Contingent Workers apply HERE

Secondary Language(s) Job Description

We keep the patient at the very heart of all that we do and strive to find solutions and treatments for some of the world's most challenging healthcare needs.

As an equal opportunity employer, we are proud to be a company that embraces the value of bringing diverse, talented, and committed people together.

Please don't hesitate to contact the Talent Acquisition Advisor assigned to this role should you need any support during our recruitment process.

We are committed to flexible working where possible, and this is why our Company has introduced a new hybrid working model for office-based colleagues around the world.

Please feel free to speak to us about what flexibility means to you during your application.

So, if you are ready to:

Invent solutions to meet unmet healthcare needs, please apply today.

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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.

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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, 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

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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:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

04/4/2026

*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:R390868

Process and Technical Engineering Lead - Dunboyne

Job Description