Job Description

The Rahway FLEx (Formulation Laboratory & Experimentation) Center is a flexible, agile facility that brings together capabilities, operations, and talent to accelerate the pipeline.

Pharmaceutical Operations & Clinical Supply is seeking applicants for a Manufacturing Engineering Lead to support specialty dosage forms and oral solid dosage (OSD) GMP development activities on second shift. The successful incumbent will serve as the technical lead for shift production, coordinating safety, quality, and equipment decisions. This role evaluates safety, product/process quality, and equipment performance and determines the appropriate path forward to protect patients, people, and compliance.

Key Responsibilities

• Own technical decisions for the shift and act as the primary production engineering point of contact for Non‑Sterile operations.

• Evaluate safety, quality, and equipment status; make real‑time technical determinations on next steps, including stop‑work when risk warrants; escalate and document per cGMP expectations.

• Serve as owner and trainer for key equipment with emphasis on specialty setups (e.g., spray drying, autoinjector assembly, potent‑processing isolators).

• Lead room readiness and equipment readiness: plan/execute room setup; equipment assembly/disassembly; cleaning; line clearance; changeover.

• Author, execute, and close GMP documentation (batch records, logs, investigations, CAPA, change controls); ensure data integrity in MES (e.g., PAS‑X) and ALCOA principles.

• Troubleshoot equipment/system issues and drive root‑cause analysis with peer specialists, formulation scientists, facility engineers, and automation engineers; implement robust corrections/preventive actions.

• Coach and develop the shift team by actively sharing knowledge, standardizing best practices, and identifying improvements that strengthen safety, quality, delivery, and cost.

• Lead improvement activities on one of the specialty equipment trains in the oral solid dosage facility

• Champion Ways of Working and continuous improvement; lead small projects from scoping through qualification and handover.

• Approves equipment disposition (repair, replace, optimize) based on condition, reliability, and product requirements; coordinates with Maintenance/Facilities, Automation, production, process engineering and formulators.

Minimum Qualifications

• Bachelor’s degree in Engineering or Science (e.g., Mechanical, Chemical, Biomedical) or equivalent GMP manufacturing experience.

• 8+ years in GMP clinical or commercial manufacturing (OSD or specialty dosage forms) with hands‑on equipment setup, cleaning, and troubleshooting.

• Demonstrated knowledge of cGMP, data integrity, batch documentation, investigations, and CAPA.

• Experience with OCT, FCT and encapsulation manufacturing; spray dryers, autoinjector assemblies, isolators (OEB4/OEB5), or comparable specialty equipment.

• Strong problem solving and root‑cause analysis skills; ability to lead and train operators/technicians on the floor.

• Ability to work second shift on‑site in classified GMP suites.

Preferred Qualifications

• MES experience (e.g., PAS‑X) and proficiency with electronic logbooks and quality systems.

• Exposure to potent compound handling and containment strategies; respirator/gowning certification a plus.

• Lean/Six Sigma certification or practical application; familiarity with TPM/RCM and basic reliability tools.

• Working knowledge of EHS risk assessment (JSA/WRAs) and equipment qualification/validation basics.

#PSCS

#eligibleforERP

Required Skills:

Accountability, Accountability, Adaptability, Chemical Engineering, Clinical Pharmacy, Corrective Action Management, Customer-Focused, Data-Driven Decision Making, Data Integrity, Dosage Forms, Drug Product Development, Estimation and Planning, GMP Compliance, Innovation, Leadership, Lean Six Sigma (LSS), Manufacturing Engineering, Manufacturing Quality Control, Mechanical Engineering, Pharmaceutical Process Development, Process Control Automation, Process Engineering, Process Optimization, Product Formulation, Project Management {+ 5 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:

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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.

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

$126,500.00 - $199,100.00

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:

Yes

Travel Requirements:

No Travel Required

Flexible Work Arrangements:

Not Applicable

Shift:

1st - Day, 2nd - Evening

Valid Driving License:

No

Hazardous Material(s):

n/a

Job Posting End Date:

01/21/2026

*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.