Associate Specialist, Process Engineering - Oral Solid Dosage, Clinical Manufacturing (Onsite)

Job Description

Associate Specialist - Process Engineer (P1)

Job Description:

The Formulation, Laboratory, and Experimentation (FLEx) Center is a multi-modality (small molecule, biologics, vaccine) drug product development and clinical manufacturing facility in Rahway, New Jersey.- The Non-Sterile Process Engineering team ensures right-first-time manufacture and delivery of high-quality drug products (spray-dried intermediates, tablets and capsules), leveraging pharmaceutical unit operations such as spray-drying, hot-melt extrusion, blending, roller compaction, encapsulation, compression, and film coating. We are part of our company's research division, focused on development and clinical deliveries in a GMP pilot facility supporting partners in Oral Formulation Sciences and Pharmaceutical Commercialization Technology to enable faster delivery of new medicines to clinical trials.

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The Non-Sterile (Oral Solids Dosage) team at the FLEx Center in Rahway is looking for an Associate Specialist - Process Engineer to lead clinical supply manufacturing with scientific rigor of processes, to ultimately enable flexibility and speed of our company's pipeline.

This person will:

• Lead on-the-floor batch manufacturing to ensure safety and quality of clinical supplies to augment and accelerate our products.
• Draft and execute GMP documentation including but not limited to batch records, equipment qualification and cleaning, technical protocols, change records and deviations.
• Analyze process data to identify areas of improvement and/or build the technical know-how of the program
• Build partnerships within and across work groups of formulators, engineers, technicians, safety and quality representatives.
• Foster a culture of collaboration, learning and innovation.

Required Experience and Skills:

• Basic understanding and extensive experience visualizing and analyzing data with Excel or comparable tools.
• Desire and willingness to learn and contribute through independent problem-solving.
• Strong interpersonal, communication, and technical writing skills; ability to lead without authority and influence cross-functional teams.
• Proven root cause analysis and problem-solving skills; continuous improvement mindset.
• Strong technical writing capabilities.

Education Minimum Requirements:

• Bachelor of Science degree in Chemical Engineering, Biomedical Engineering, Chemistry, Pharmaceutical Sciences or related scientific field (with expected completion no later than June 2026)

Preferred Experience and Skills:

• Knowledge of drug product processing.
• Foster a culture of collaboration, learning and innovation.
• Experience with Commissioning, Qualification and Validation
• Experience with unit operations for solid oral dosage form manufacturing, including spray drying and hot melt extrusion

Schedule:

This role supports operational coverage across multiple shifts. Candidates must be willing and able to float between 1st and 2nd shift.

Work schedules for this role will vary based on the needs and timing of assigned campaigns. While standard working hours will apply most of the time, there may be occasions when you are required to work earlier, later, or extended hours to support campaign requirements. Reasonable notice of schedule changes will be provided whenever possible.

FLEx2026

#PSCS

#eligibleforERP

#NSBE2026

Required Skills:
Accountability, Accountability, Biomedical Engineering, Biomedical Sciences, Biopharmaceutics, Chemical Engineering, Clinical Trials, Communication, Contractor Oversight, Driving Continuous Improvement, Drug Development, Emergency Care, Engineering Standards, Equipment Qualification, Estimation and Planning, GMP Compliance, GMP Validation, Immunochemistry, Interpersonal Communication, Lean Manufacturing, Manufacturing Quality Control, Manufacturing Scale-Up, Orthopedics, Process Control, Process Optimization {+ 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
$71,900.00 - $113,200.00

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 .

You can apply for this role through (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:
10%

Flexible Work Arrangements:
Not Applicable

Shift:
1st - Day, 2nd - Evening

Valid Driving License:
No

Hazardous Material(s):
n/a

Job Posting End Date:
03/30/2026
*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: R388864