Sterile Process Engineer, Specialist; On-site

Job Description

The Formulation, Laboratory, and Experimentation (FLEx) Center is a new multi-modality (small molecule, biologics, vaccine) Drug Product development and Good Manufacturing Practice (GMP) clinical supply manufacturing facility in Rahway, New Jersey.

The Sterile Process Engineer role at the Specialist level will leverage the individual’s leadership, technical, and communication skillsets to drive the success of our clinical manufacturing facility and organization.

This role will support the pipeline’s most technically complex formulations and process development through process tech transfer, scale-up activities, quality investigations, change management, and authoring GMP standard operating procedures and protocols in support of sterile clinical drug product operations. This individual will collaborate closely with the formulation scientists, engineers, operations staff, quality representatives, and other team members to ensure the quality of the clinical supplies, the scientific rigor of the processes, and ultimately to enable the flexibility and speed of our Company's pipeline.

The role is, on-site, based in New Jersey and reports to the Sterile Process Engineering Lead of the FLEx GMP facility within Pharmaceutical Operations and Device Development (PSDD).

• Bachelor’s degree in Chemical Engineering, Chemistry, Pharmaceutical Sciences or related scientific field with a minimum of 3 years relevant experience
• Master’s degree in Chemical Engineering, Chemistry, Pharmaceutical Sciences or related scientific field (with expected completion no later than June 2027).

• Excellent enterprise leadership skill demonstration
• Excellent interpersonal and communication skills, both verbal and written.
• Experience in leading quality investigations and change management.
• Familiarity with United States and European Union GMP and Safety compliance regulations.
• Ability to convert new drug product attributes and process needs to an executable series of steps and procedures to enable acceptable product manufacture.
• Ability to prepare Standard Operating Procedures (SOP) and current GXP documents.
• Experience with quality systems.
• Excellent organizational skills.
• Desire and willingness to learn, contribute and lead.
• Track-record of independent problem-solving.

• Experience with sterile GMP facility operations.
• Knowledge of Investigational drug regulatory requirements.
• Understanding of Clinical Supply Chain Operations.
• Expertise in drug product aseptic processing, equipment, and sterile technique.

Aseptic Processing, cGMP Guidelines, Electronic Batch Records, Laboratory Experiments, Pharmaceutical Regulatory Compliance, Pharmaceutical Sciences, Pilot Plant Operations, Process Engineering, Process Improvements, Standard Operating Procedure (SOP), Sterile Manufacturing, Technology Transfer, Troubleshooting

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities.

We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance.

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.

Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search…