Specialist, Engineering

Job Description Description The Modality Agnostic Chemistry Scaleup (MACS) Operations group within the Chemical Engineering Research & Development (CERD) Department is seeking a highly motivated individual to work in a fast-paced job that provides a high degree of technical and project management responsibility. The Specialist – Process/Facility Engineering position will report to an Associate Director, Engineering as a member of the MACS Operations Team at the Rahway NJ facility. Responsibilities of the Specialist – Process/Facility Engineer include the following: The process engineer role at the Specialist level will serve as a process team member supporting the Modality Agnostic Chemistry Scaleup (MACS) Center. This is a new potent, multi-modality (small molecule, macrocyclic peptides, bioconjugates) Drug Substance development and GMP clinical manufacturing plant currently planned in Rahway, New Jersey. The Specialist will work alongside their peers in the MACS Operations Team, with the Enabling Facilities group and other operations areas such as the SSO and Prep Lab (see below), as well as key stakeholders in Process R&D, Analytical, Quality, and Safety. They will be instrumental in setting up this first-of-a-kind facility by the ready for science target date of 2Q 2027. As the MACS facility is currently under construction, the selected candidate will contribute to equipment and facility design, system commissioning/qualification, as well as other critical activity workstreams to enable facility startup and subsequent batch processing. The selected candidate is expected to be a key part of a team of process/facility engineers, supervisors, and operations specialists to drive the work and foster a culture of collaboration, learning and innovation. They will collaborate closely with the development engineers & chemists, compliance and safety representatives, and other team members to ensure the quality and safe delivery of clinical supplies, the scientific rigor of the processes, and ultimately to enable flexibility and speed of the Company’s pipeline. This role may support facility operations, process development activities, support compliance investigations/change management, author GMP documentation and manage/lead engineers in any of our enabling facilities. Additional Supported Areas: As required and in addition to support of current capital projects the Specialist may provide direct support to other areas such as: Small Scale Organics Pilot Plant (SSO): The SSO is a Good Manufacturing Practice (GMP) manufacturing facility in the Process Research and Development (PR&D) organization. The pilot plant’s mission is to serve as PR&D’s internal node for small molecule drug substance clinical manufacture, and as preferred site for first pilot of commercial small molecule processes, enabling gain of critical internal experience with scale-up of manufacturing GMP steps, demonstration of new manufacturing technology/processes, training opportunities for improved manufacturing process development and seamless tech transfer to commercial sites. Prep Lab Area : The Prep Lab is used to generate data which contributes to process definition and provides Phase I/IIa clinical material when needed. This kilo scale capability establishes reaction parameters and ensures successful batches when transferring to pilot scale. Areas of the Prep Lab have been and are continuing to be upgraded to support pipeline programs such as ADCs, PDCs, and other cross modality compounds that require a more flexible potent compound processing space. Education Minimum Requirement: Bachelor’s degree in Chemical Engineering, Chemistry, Biology, Pharmaceutical Sciences or related scientific field with minimum of 3 years relevant experience, or Master’s degree with 1 year of relevant experience. Required Experience and Skills: Working in a GMP clinical or manufacturing supply facility. GMP facility design, equipment start-up and/or qualification. Small and/or large molecule drug substance process development. Supporting compliance investigations and change management. Familiarity with US and EU GMP and Safety compliance regulations Ability to convert new drug substance process needs to an executable series of steps and procedures to enable acceptable product manufacture. Ability to prepare Standard Operating Procedures (SOP) and cGMP documents. Effective interpersonal and communication skills, both verbal and written. Excellent organizational skills to multi-task. Desire and willingness to learn, contribute and lead. Track-record of independent problem-solving. Desired Experience and Skills: Operating/maintaining pilot scale or prep lab scale equipment. Process Hazard Analysis (PHA) and/or Level of Protection Analysis (LOPA). Providing technical mentorship. Potent Compound processing and containment systems (e.g., isolators). Quality systems Interacting with or overseeing the management of process utility system associated with a large drug substance pilot plant including WFI generation/distribution, Process Chillers, Vacuum Systems, etc. Working in an environment with an Automation System (DeltaV, PLC, etc.). Coordinating maintenance activities around processing activities to support reliable facility operation. Required Skills: cGMP Guidelines, Chemical Engineering, Electronic Batch Records, Facility Engineering, Pilot Plant Operations, Process Engineering, Quality Control Systems, Safety Compliance, Standard Operating Procedure (SOP), Troubleshooting Preferred Skills: Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. 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