Sr. Specialist, Engineering (Onsite)

Join the Formulation, Laboratory, and Experimentation (FLEx) Center, 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 Senior Specialist level will leverage leadership, technical, and communication skills to drive success in our clinical manufacturing facility and organization.

About the role

This position supports the pipeline’s most technically complex formulations and process development through process tech transfers, scale-up activities, quality investigations, change management, and authoring GMP standard operating procedures and protocols for sterile clinical drug product operations. You will collaborate closely with development scientists, engineers, operations, quality representatives, and other team members to ensure the quality of clinical supplies, scientific rigor of processes, and enable the flexibility and speed of our company's pipeline.

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

Responsibilities

• Lead quality investigations and change management.
• Convert new drug product attributes and process needs into executable steps and procedures for acceptable product manufacture.
• Prepare Standard Operating Procedures (SOP) and current GXP documents.
• Support process tech transfers and scale-up activities.
• Collaborate with cross-functional teams to ensure compliance with GMP and safety regulations.
• Drive independent problem-solving and technical leadership in sterile drug product operations.

Requirements

Education Minimum Requirements:

• Bachelor’s degree in Chemical Engineering, Chemistry, Pharmaceutical Sciences, or related scientific field with a minimum of 5 years relevant experience.
• Master’s degree in Chemical Engineering, Chemistry, Pharmaceutical Sciences, or related scientific field with a minimum of 3 years relevant experience.
• PhD in Chemical Engineering, Chemistry, Pharmaceutical Sciences, or related scientific field with relevant experience.

Skills

Required Experience and Skills:

• Excellent enterprise leadership and interpersonal communication skills.
• Familiarity with United States and European Union GMP and safety compliance regulations.
• Experience with quality systems, deviation management, and root cause analysis (RCA).
• Ability to author GMP documents, including SOPs and protocols.
• Strong organizational and technical problem-solving skills.
• Track-record of independent problem-solving and adaptability.

Preferred Experience and Skills:

• Experience with sterile GMP facility startup.
• Knowledge of investigational drug regulatory requirements.
• Understanding of clinical supply chain operations.
• Expertise in drug product aseptic processing, equipment, and sterile technique.

Pay

The salary range for this role is $117,000.00 - $184,200.00. An employee’s position within the salary range will be based on factors including education, qualifications, certifications, experience, skills, geographic location, and business needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

Benefits

We offer a comprehensive package of benefits, including:

• Medical, dental, vision, and other insurance benefits for employee and family.
• Retirement benefits, including 401(k).
• Paid holidays, vacation, compassionate, and sick days.

More information about benefits is available at Merck Compensation and Benefits.

Schedule

• Shift: 1st - Day
• Travel Requirements: 10%
• Relocation: Domestic relocation assistance available.
• Visa Sponsorship: Not available for this role.