Sr. Specialist, Engineering (Onsite)

MSD•Rahway, NJ

5d•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 currently in operational startup. The Senior Specialist, Technical Operations – Engineering will serve as a key technical specialist for the FLEx Sterile Expansion Project, focused on the Optima multi-use filling line. The expansion will add a second clinical filling and lyophilization suite, a formulation suite, a sterile supply suite, and supporting infrastructure and utilities, more than doubling the facility’s capacity. The selected candidate will complete 10–12 weeks of in-person Optima Super User training in Germany and become proficient in mechanical, automation, and system-wide troubleshooting. After training, this person will support commissioning and qualification of the filling line and collaborate with formulation scientists, capital design engineers, safety and quality representatives, digital and IT teams, equipment vendors, and other stakeholders through project commissioning, qualification, and startup. Once operations commence, the role will work closely with formulators, engineers, Quality representatives, and other team members to support the quality of clinical supplies, scientific rigor, and flexibility and speed of the sterile pipeline. The position involves working with aseptic drug product filling and lyophilization equipment throughout the manufacturing cycle, performing manual and automated operations, maintenance, troubleshooting, documentation, and aseptic manipulations within Grade A barrier isolation systems. The role requires flexibility in working hours and overtime based on business needs, and international travel for the required 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 at least 3 years of relevant experience.
Ability to complete 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 for the mandatory 10–12 week training program in Germany.
Flexibility to work varying hours and overtime as required in manufacturing.

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, and 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 develop knowledge of equipment and facility design, maintenance, troubleshooting, operational excellence, financial and capital management, team building, process sciences, technical writing, and networking.
Work with state-of-the-art aseptic drug product filling and lyophilization equipment and complete processes throughout the manufacturing cycle.
Attend and complete 10–12 weeks of 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, meetings, and other activities as needed to improve job skills and product-related procedures.