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Job Description

Applications are sought for a Process Engineering Lead position in our Reseach & Development Division Biologics Process Research & Development (BPR&D). The incumbent will support GMP capability build for the production of clinical supplies of bulk biologic drug substance at a state-of-the-art Next Generation Biologics (NGB) facility at our company Rahway, NJ site. By integrating leading-edge technology with a dynamic, activity-based workspace, the facility will support seamless connection and collaboration within and across teams and functions.

The NGB GMP clinical manufacturing building will be a new entirely single-use facility, and this opportunity is for an individual to join our Reseach & Development Division project team as a leader at the detail design phase in preparation for operational readiness. This is an exciting opportunity to enter the team on the ground floor, manage a broad scope of activities, understand the RY and BPR&D facility network, learn to work in a dynamic team environment while building a collaborative network, and will require agility and flexibility to meet business needs.

As leader of the Process Engineering group, the incumbent will be responsible for the evaluation and implementation of novel equipment, innovative processes, and the implementation of next generation technologies to keep our company at the forefront of innovation in development and clinical manufacturing of biologics. Over time the incumbent will manage a small organization of 3-4 exempt and non-exempt employees to support bulk clinical manufacturing of biologic drug substances, and at times will require hands-on approach on the processing floor.

Responsibilities Include:

+ Serve as an engineering resource for biologics operations, build strong equipment knowledge, lead projects, and provide guidance and training to operationalize the GMP operations and staff.

+ Lead team and coordination efforts with colleagues across the local site and global our company network in shaping and implementing next generation technologies and innovation for GMP Fed Batch and Continuous Manufacturing in Drug Substance.

+ Lead tiered meeting structure coordinating activities locally and with international (US, Ireland, Switzerland) groups for implementation of new processes and technologies for Drug Substance.

+ Be a change champion within the organization and site, to bring about new technologies, digitization, and ways of working.

+ Act as an SME for the evaluation of innovative equipment for optimizing manufacturing processes, preparing user requirements and capital funding requests:

+ Work to harmonize technologies in batch and continuous manufacturing, for easy flexibility in switching between the two paradigms.

+ Implement new technologies / software / instruments/ single-use assemblies that can simplify and reduce effort around manufacturing and administrative processes.

+ Support the development of GMP Documentation such as: Risk Assessments, Batch Records, Sampling Plans, Qualification Documents, and SOPs.

+ Aggregate process related knowledge and centralize for knowledge management.

+ Work with different cultures and backgrounds to form an effective working relationship within a cross-functional team.

+ Recruit, manage and engage personnel, plan and assign work, and manage performance. Provide guidance, coaching and mentorship, motivating staff to achieve department/personal objectives.

+ Provide timely performance feedback and foster culture of trust for open dialogue.

+ Coach team in the development planning process for soft and technical skills.

+ Leadership Skills: Ability to provide functional leadership through delegating, developing, and motivating employees. Establish and maintain productive cross-functional partnerships with diverse groups internal to the organization and with key stakeholders.

+ Training skills: Ability to train employees in technical, compliance, safety, and environmental procedures; ability to write SOPs and technical documents and present to peers and senior management.

+ Analytical skills: Ability to analyze complex data and make recommendations for actions.

+ Project Management skills: Ability to serve as subject matter expert and lead multidisciplinary project teams.

+ Communication skills: Strong organization, negotiation, presentation, written, and verbal skills.

+ Innovation Skills: Ability to conceive and implement innovative technologies that can reduce cost and production lead time. Able to implement and facilitate changes. Effectively apply state-of-the-art technologies and best practices to improve operational efficiency.

+ Planning/Strategic Thinking: Ability to develop goals/objectives and translate them into action plans that benefit the department long term.

Education Minimum Requirement:

BS with greater than 8-10 yrs experience. MS or Ph.D. degree in Biological Science, Engineering or Life Science with greater than 5 yrs experience.

Required Experience and Skills:

+ A minimum of 7 years relevant experience in biopharmaceuticals. Demonstrated ability to lead functional groups with proven people management and talent development skills.

+ Strong knowledge of engineering principles, commissioning and qualification, biologics unit operations in a single-use environment, and bioprocessing equipment

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

+ Experience with facility fit assessments, transfer of processes to and from clinical site, and clinical manufacturing experience.

+ The incumbent should be highly motivated with the ability to work in a fast-paced setting.

+ Experience as a Project Manager with cross-functional team members or Managing Staff.

+ Competent in analyzing complex situations and show practical problem-solving capabilities.

+ Effective oral / written communication skills.

Preferred Experience and Skills:

+ Previous experience in process engineering, upstream and/or downstream technical support or manufacturing operations for biologics and/or vaccine products.

+ Experience with operationalization of GMP operations and/or large facility builds or renovations.

+ A thorough understanding of regulatory/compliance expectations across all phases of product development and commercialization.

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”.

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:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Not Applicable

Shift:

Valid Driving License:

Hazardous Material(s):

Required Skills:

Adaptability, Adaptability, Applied Engineering, Biological Sciences, Biopharmaceuticals, Biopharmaceutics, Chemical Engineering, Customer-Focused, Data-Driven Decision Making, Digitizing, Drug Product Development, Estimation and Planning, Fast-Paced Environments, GMP Compliance, Innovation Processes, Life Science, Manufacturing, Manufacturing Process Improvements, Manufacturing Quality Control, Operational Efficiency, Pharmaceutical Process Development, Process Control Automation, Process Engineering, Process Optimization, Product Development {+ 5 more}

Preferred Skills:

Job Posting End Date:

09/17/2025

*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:** R365311