Senior Specialist -Engineering

MSD • Rahway, NJ

6d • Onsite

About The Position

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 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 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.

Requirements

• Bachelor’s degree in Chemical Engineering, Chemistry, Biology, Pharmaceutical Sciences or related scientific field with minimum of 5 years relevant experience, or a Master’s degree with 4 years of relevant experience, or a PhD degree with 1 years of relevant experience.
• Experience in GMP clinical supply facility.
• Experience with GMP facility design, equipment start-up and/or qualification.
• Experience with small molecule drug substance and/or biologics process development.
• Experience in supporting compliance investigations and change management.
• Familiarity with US and EU GMP and Safety compliance regulations
• Experience in Process Hazard Analysis (PHA) and/or Level of Protection Analysis (LOPA)
• 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.

Nice To Haves

• Experience operating/maintaining pilot scale or prep lab scale equipment.
• Experience providing technical mentorship.
• Experience with Potent Compound processing and containment systems (e.g., isolators).
• Experience performing and/or overseeing quantitative industrial hygiene (IH) exposure evaluations.
• Experience with Quality systems
• Experience 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.
• Experience working in an environment with an Automation System (DeltaV, PLC, etc.).
• Experience with coordinating maintenance activities around processing activities to support reliable facility operation.

Responsibilities

• 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.
• Support of current capital projects.
• Provide direct support to other areas of Rahway such as: Small Scale Organics Pilot Plant (SSO) and Prep Lab Area.

Benefits

• medical, dental, vision healthcare and other insurance benefits (for employee and family)
• retirement benefits, including 401(k)
• paid holidays, vacation, and compassionate and sick days
• annual bonus
• long-term incentive

What This Job Offers

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