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

Merck • Rahway, NJ

1d • Onsite

About The Position

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 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.

Requirements

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

Nice To Haves

• 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

Responsibilities

• 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.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level