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

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 Solids Dosage) team at the FLEx Center in Rahway is looking for a Sr. Specialist - Process Engineer to lead clinical supply manufacturing with scientific rigor of processes, to ultimately enable flexibility and speed of our companys pipeline.

This person will:

• Lead on-the-floor batch manufacturing in a pilot plant while prioritizing and ensuring safety and quality of clinical supplies.
• Author and review GxP documentation including but not limited to batch records, specifications, equipment qualifications, change records and deviations.
• Facilitate and support early process development by assisting in lab activities, and sharing knowledge transfer for scaling at pilot plant scale with relevant partners, via technical reports and presentations.
• Propose new, innovative approaches for enhanced product understanding and/or process development, generate experimental designs, execute experimental plans, and interpret data.
• Support process development activities using Design of Experiments for new chemical entities or life cycle management opportunities.
• Identifies and resolves technical and operational problems; collaborating with peers to resolve problems that cross into inter-related units
• Build partnerships by developing and leveraging relationships within and across work groups of formulators, engineers, safety and quality representatives.
• Foster 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 | 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 minimum of 5 years relevant experience, or a Master's degree with 3 years of relevant experience, or a PhD degree (with expected completion no later than June 2026).

Preferred Experience and Skills

• Pharmaceutical development experience.
• Demonstrated ability to identify, fundamentally characterize, and address manufacturing challenges through the development, optimization and execution of novel production technologies.
• 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.
• Desire to build new capabilities through the evaluation of new technologies and hands-on optimization of existing technologies.
• Demonstrated ability to apply the principles of physical/organic chemistry, physical pharmacy, and materials science to solving practical pharmaceutical development problems.
• Hands-on experience in pharmaceutical manufacturing plants.

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.

Required Skills

• Accountability
• Adaptability
• Analytical Testing
• Biomedical Engineering
• Chemical Engineering
• Chemical Physics
• Data Analysis
• Detail-Oriented
• Deviation Management
• Emergency Care
• Engineering Standards
• Equipment Qualification
• GMP Compliance
• Good Manufacturing Practices (GMP)
• Materials Science
• Organic Chemistry
• Orthopedics
• Pharmaceutical Development
• Pharmaceutical Manufacturing
• Pharmacy
• Process Design
• Process Engineering
• Process Hazard Analysis (PHA)
• Process Optimization

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.

Equal Employment Opportunity

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

Diversity and Inclusion

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.

Salary and Benefits

The salary range for this role is $117,000.00 - $184,200.00. 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, including 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.

Application and Hiring Process

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 note that 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.

Job Details

• Employee Status: Regular
• Relocation: Domestic
• VISA Sponsorship: Yes
• 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: 03/26/2026