Sr. Specialist, Engineering (Onsite)

Merck•Rahway, NJ

6d•$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 operational startup. The facility supports clinical products across modalities including sterile small molecules, biologics, vaccines, and antibody-drug conjugates. This Senior Specialist will serve as a technical specialist on the FLEx Sterile Expansion Project, focused on the Optima multi-use filling line. The project will expand facility capacity by adding a second clinical filling and lyophilization suite, a formulation suite, a sterile supply suite, and supporting infrastructure and utilities. The selected candidate will complete a mandatory 10–12 week in-person training program at Optima facilities in Germany, developing proficiency in mechanical, automation, and system-wide troubleshooting. After training, the individual will support commissioning and qualification of the filling line and facility startup. The role involves collaboration with 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 the quality of clinical supplies, scientific rigor of processes, and flexibility and speed of the sterile pipeline. The position is based in Rahway, New Jersey, and requires international travel for training and additional travel as necessary. Hours may vary with business needs, and overtime flexibility is required in manufacturing.

Requirements

Bachelor’s degree in Mechatronics, Engineering, Automated Sciences, Computer Science, Biology, Chemistry, or equivalent, with at least 5 years of relevant experience; alternatively, a master’s degree with at least 3 years of relevant experience.
Ability to complete required gowning and use personal protective equipment, including 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 full 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, 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 build 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 through manufacturing processes.
Attend and complete the 10–12 week Optima Super User training program at 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 batch and equipment preparation documentation.
Identify compliance, environmental, safety, and process deviations; address them as appropriate and notify the appropriate personnel.
Demonstrate safe work habits and maintain a safe work environment while complying 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.
Support commissioning, qualification, and startup activities for the multi-use filling line and facility expansion.