Senior Process Engineer - Non-Sterile Operations (On-site)

Merck & Co.; Rahway (NJ); On-site; USD 117,000 - 184,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) plan

Paid holidays

Job summary

Merck & Co. in Rahway, NJ, seeks a Sr. Specialist - Process Engineer to lead clinical supply manufacture in pilot facilities, ensuring high quality and safety.

The role emphasizes GxP documentation, problem-solving across units, and collaboration with multiple teams to advance early development and scale-up. The ideal candidate has a strong background in small molecule manufacturing, DoE, and quality investigations, with 5+ years in related roles.

Qualifications

• Bachelor of Science in Chemical Engineering, Chemistry, or related field with 5+ years of experience; or Master’s with 3+ years; or PhD with expected graduation by Dec 2026.
• Experience in GMP pilot plant or commercial manufacturing environment.
• Knowledge of small molecule drug product manufacturing technologies (blending, granulation, compression, encapsulation, film coating, spray drying, hot-melt extrusion).

Responsibilities

• Lead on-the-floor batch manufacturing in a pilot plant, ensuring safety and quality of clinical supplies.
• Draft and execute GxP documentation: batch records, equipment qualification, cleaning, change records, deviations.
• Identify and resolve technical/operational problems, collaborating across units.
• Support early process development and knowledge transfer for scaling at pilot plant scale, via technical reports and presentations.
• Propose innovative approaches for enhanced process and product understanding.
• Support process development using Design of Experiments for new entities or lifecycle opportunities.
• Build partnerships across formulators, engineers, safety, and quality teams.
• Foster collaboration and set measurable short- and long-term goals.

Skills

GxP Regulations

Process Engineering

DoE

Root Cause Analysis

Quality Investigations

Automation Integration

Cross-functional Collaboration

Education

B.S. in Chemical Engineering

M.S. in Chemical Engineering

Ph.D. in Chemical Engineering

Job description

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.

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

This person will:

• Lead on-the-floor batch manufacturing in a pilot plant while prioritizing and ensuring safety and quality of clinical supplies.
• Draft and execute GxP documentation including, but not limited to, batch records, equipment qualification and cleaning, change records and deviations.
• Identify and resolve technical and operational problems, collaborating with peers to resolve problems that cross into interrelated units .
• Facilitate and support early process development by assisting in lab activities, and supporting knowledge transfer for scaling at pilot plant scale with relevant partners, via technical reports and presentations.
• Propose new, innovative approaches for enhanced process and product understanding.
• Support process development activities using Design of Experiments for new chemical entities or life cycle management opportunities.
• Build partnerships by developing and leveraging relationships within and across work groups of formulators, engineers, safety and quality representatives.
• Foster a culture of collaboration, learning and innovation. Support in setting specific and measurable short- and long-term goals.

Required Experience and Skills:

• Proven ability to identify and develop innovative ideas.
• Strong problem-solving skills and a direct involvement approach to problem solving.
• The candidate should be able to examine an issue from diverse perspectives (safety, compliance, automation, equipment, process, and people) to best understand and identify root cause.
• Demonstrated ability to independently design and execute complex experiments and analyze data.
• Familiarity with GMP and safety compliance regulations.
• Ability to work effectively with team members of diverse skill sets and backgrounds.
• Strong interpersonal and communication skills, both verbal and written.

Education Minimum Requirements:

• Bachelor of Science degree in Chemical Engineering, Biomedical Engineering, Chemistry, Pharmaceutical Sciences or related scientific field with a minimum of 5 years relevant experience,
• or a Master's degree in Chemical Engineering, Biomedical Engineering, Chemistry, Pharmaceutical Sciences or related scientific field with 3 years of relevant experience,
• or a PhD in Chemical Engineering, Biomedical Engineering, Chemistry, Pharmaceutical Sciences or related scientific field (with expected graduation no later than December 2026).

Preferred Experience and Skills:

• Experience executing GxP manufacturing in a pilot plant or a commercial manufacturing environment.
• Experience with small molecule drug product manufacturing technologies, including: blending, granulation, compression, encapsulation, film coating, spray drying, and hot-melt extrusion.
• Experience with process modeling, simulation, and automation integration in the pharmaceutical and/or industrial manufacturing sector.
• Experience or interest in supporting electronic batch records and MES systems.
• Experience in leading and supporting quality investigations and change management.
• Experience with Commissioning, Qualification and Validation.
• Knowledge of investigational drug regulatory requirements.
• Understanding of Clinical Supply Chain Operations.
• Demonstrated ability to identify, fundamentally characterize, and address manufacturing challenges through the development, optimization and execution of novel production technologies.
• Desire to build new capabilities through the evaluation of new technologies and hands‑on optimization of existing technologies.

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.

Hours:

1st shift - 7:30am - 4pm

2nd shift - 3pm - 11:30pm

Required Skills:

Chemical Engineering, Deviation Management, Drug Product Manufacturing, Equipment Qualification, Good Manufacturing Practices (GMP), GxP Regulations, Manufacturing Process Engineering, Oral Solid Dosage, Pharmaceutical Industry, Process Design, Process Optimization, Root Cause Analysis (RCA)

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.

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

Location:

The primary location for this posting is: USA - New Jersey - Rahway

Additional location(s): Please note the salary range above applies to the Primary Location of the position. Where a role has other listed locations, different compensation guidelines may apply. You may find the salary ranges for additional locations below. If the salary range is not listed for the location you are applying to, our Talent Acquisition team will provide further information to you relevant to your location.

Salary:

The salary range for the primary location of this role is:
$117,000.00 - $184,200.00

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 .

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):

organic solvents, APIs