Senior Specialist -Engineering

** Job Description*
* The Modality Agnostic Chemistry Scaleup (MACS) Operations team 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. This Senior Specialist position will report to a MACS Facility Lead (Associate Director, Engineering) as a part of the core engineering team supporting the MACS facility.

The incumbent will hold a process engineering role, serving as both an individual contributor and a technical mentor to support the MACS facility - a new, potent, multi-modality (small molecule, macrocyclic peptides, bioconjugates) Drug Substance development and GMP clinical manufacturing pilot plant currently under construction in Rahway, New Jersey. The engineer will be expected to exhibit a mindset of safety and quality compliance, which will include following current Good Manufacturing Practices (cGMPs), and participating in risk assessments, deviation investigations, and Good Documentation Practices (GDocP).

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 work streams 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 and foster a culture of collaboration, learning and innovation. They will collaborate closely with the development engineers & chemists, compliance 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.

** Key responsibilities of this role include:*
* + Leverage depth and breadth of scientific, technical, and operational experience to support facility start up and long-term operations.

+ Author and review documentation required for facility start up, non-GMP and GMP operations.

+ Cleaning and Containment Verification (CCV) for the suite of specialized equipment for MACS potent processing - includes managing the CCV strategy, providing shop floor support for testing, and working with key partners in Analytical, Quality, and Safety for testing.

+ Industrial Hygiene strategy and controls - includes working with Safety & Environmental partners.

+ Provide mentorship and oversight for the extended team to progress facility needs.

Additional Supported Areas

As required and in addition to support of current capital projects the Senior Specialist may provide direct support to other areas of Rahway 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 Antibody Drug Conjugates (ADCs), Peptide Drug Conjugates (PDCs), and other cross modality compounds that require a more flexible potent compound processing space.

** Education Minimum Requirement: *
* Bachelor's degree…