Sr. Specialist, Engineering (Onsite)

MSD • Rahway, NJ

1d • $117,000 - $184,200 • Onsite

About The Position

The Formulation, Laboratory, and Experimentation (FLEx) Center in Rahway, New Jersey, includes a sterile drug product cGMP clinical supply manufacturing facility that is in its operational startup phase. The FLEx Sterile Expansion Project will more than double the existing facility’s capacity by adding a second clinical filling and lyophilization suite, a formulation suite, a sterile supply suite, and supporting infrastructure and utilities.

The Senior Specialist, Technical Operations – Engineering will serve as a key technical specialist for the expansion project, with a focus on the Optima multi-use filling line. The selected candidate will complete 10–12 weeks of in-person super-user training at Optima facilities in Germany and develop proficiency in mechanical, automation, and system-wide troubleshooting. After training, the candidate will support commissioning and qualification of the filling line and contribute to project execution and startup.

The role involves collaboration with research formulation scientists, capital design engineers, safety and quality representatives, digital and IT teams, equipment vendors, and other stakeholders. Once operations commence, the specialist will work with formulators, engineers, Quality representatives, and other team members to support clinical supply quality, scientific rigor, and flexibility and speed in the company’s sterile pipeline. The position is based in Rahway, New Jersey, and requires flexibility to work varying hours and overtime as business needs require, as well as travel for vendor training.

Requirements

• Bachelor’s degree in Mechatronics, Engineering, Automated Sciences, Computer Science, Biology, Chemistry, or equivalent, with at least 5 years of relevant experience; or a master’s degree with a minimum of 3 years of relevant experience.
• Ability to perform required gowning and use personal protective equipment, such as a Powered Air Purifying Respirator.
• Strong attention to detail and documentation skills.
• Ability to communicate and work in partnership with other employees in a manufacturing environment.
• Ability to prepare Standard Operating Procedures and current GXP documents.
• Demonstrated problem-solving and troubleshooting skills.
• Effective verbal and written communication skills.
• Familiarity with United States and European Union cGMP and safety compliance regulations.
• Experience in drug product aseptic processing, equipment, and aseptic technique.
• Willingness and ability to travel internationally and complete the mandatory 10–12 week in-person training program in Germany.
• Flexibility to work varying hours based on business needs and overtime as required in a manufacturing environment.

Nice To Haves

• Experience with automated aseptic filling lines.
• Experience with smart technologies, such as robots, automated systems, and/or computer-integrated manufacturing equipment (mechatronics).
• Experience operating, setting up, disassembling, and adjusting complex equipment, such as robotics, packaging machinery, or automatic assembling machines.
• Experience with quality systems.
• Experience with new GMP facility startup.
• Experience supporting commissioning, qualification, and validation.
• Experience supporting quality investigations and change management.

Responsibilities

• Collaborate with stakeholders to gain knowledge of equipment and facility design, maintenance, troubleshooting, operational excellence, financial and capital management, team building, process sciences, technical writing, and networking.
• Work with aseptic drug product filling and lyophilization equipment and complete processes throughout the manufacturing cycle.
• Attend and complete the 10–12 week Optima Super User training at the Optima sites in Germany.
• Provide operators and engineers with training in advanced troubleshooting and support functions.
• Support individual project assignments and contribute to facility and process equipment innovation.
• Perform manual and/or automated operations, general maintenance, troubleshooting, and support functions.
• Perform aseptic manipulations within Grade A barrier isolation systems.
• Maintain contemporaneous records, including equipment and area cleaning and use logs and relevant batch and equipment preparation documentation.
• Identify and address compliance, environmental, safety, and process deviations as appropriate, and notify appropriate personnel.
• Demonstrate safe work habits and maintain a safe work environment; comply with safety and company policies and procedures.
• Attend training classes, workshops, and meetings as needed to improve job skills and product-related procedures.
• Support commissioning, qualification, and startup activities for the Optima multi-use filling line and expansion project.

Benefits

• Medical, dental, vision healthcare, and other insurance benefits for employees and family.
• Retirement benefits, including 401(k).
• Paid holidays, vacation, compassionate days, and sick days.
• Eligible for an annual bonus and long-term incentive, if applicable.
• Domestic/international relocation listed as available.

What This Job Offers

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