Contractor Liaison / Mechanical Coordinator (On-site)

Job description

Job Description Role Summary: The Enabling Facilities group within the Chemical Engineering Research & Development Department is seeking a highly motivated individual to work in a fast-paced job that provides a high degree of practical technical, mechanical and planning responsibility. The Contractor Liaison / Mechanical Coordinator position will report to the Associate Director, Engineering and will be a member of the Equipment Development and Facility Engineering team at the Rahway NJ facility. Enabling Facilities is responsible for development of new technologies/capabilities, execution of capital and non-capital improvement projects, and the automation system assets spanning production, utility systems and associated infrastructure. Equipment Development and Facility Engineering role within Enabling Facilities includes design, installation, qualification, startup, maintenance and troubleshooting and continuous improvement of equipment. Responsibilities: This role at the Specialist level will serve as a 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 Good Manufacturing Practice clinical manufacturing plant currently being constructed in Rahway, New Jersey. The Specialist will contribute to completing the capital project by supporting construction close-out, equipment and facility commissioning/qualification, as well as other critical operations readiness activity workstreams and will support the facility’s operations after start-up in 2027. Upon start-up, the selected candidate will lead the daily mechanical activities and be responsible for the planning, execution and supervision of preventative and corrective maintenance, facility improvements and yearly shutdown/turnaround efforts executed primarily by 3rd party contractors/vendors. This will involve learning, understanding, and applying the facility’s maintenance requirements and the safe work practices in effect at the Rahway site to prepare the facility and our 3rd party partners to execute said maintenance and improvement activities. This role additionally includes managing the contractor safety/management program for the MACS Center in compliance with company guidelines. Daily activities include: Prioritization of mechanical work to meet the timelines of the business, Managing external vendors and ensuring compliance with global and site safety procedures regarding 3rd Party contractor management (i.e. sourcing, qualifying, training and work oversight), Issuing hazardous permits including line breaks, Class A & B hot work, elevated work, roof access and confined space entry, Lockout/Tagout and Energy Control Procedure implementation and development, Troubleshooting and supporting emergency repairs, Guiding routine preventative maintenance and equipment calibrations, Partnering with other Equipment Development and Facility Engineering Mechanical Coordinators supporting other components of the MACS Center strategic maintenance plan, Process Equipment set-up and re-qualifications, Supporting the design and execution of small expense and capital facility modifications, Materials sourcing and coordinating with procurement, and Interaction with Computerized Maintenance Management System applications. The candidate will drive and ensure safe operations by our 3rd party partners liaise with operations specialists, facility engineers, compliance representatives, and other team members to ensure a safe work environment, the quality and safe delivery of clinical supplies, and an optimized work plan. A successful candidate will stay well attuned to the status of production activities and the readiness of maintenance work in a very dynamic production environment and will adjust priorities of the work on an ongoing basis, which ultimately will contribute to the flexibility and speed of the Company's pipeline. Additional Supported Areas: The Specialist may also support new and/or existing facilities across the Small Molecule Process Research & Development network and Enabling Facilities capital projects as required. Examples of these other areas are: Small Scale Organics Pilot Plant (SSO): The SSO is a Good Manufacturing Practice manufacturing facility in the Process Research and Development organization.  The pilot plant’s mission is to serve as Research and Development 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 Good Manufacturing Practice 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: BS in Engineering with 3+ years’ experience consisting of a mix of Project Engineering / Contractor Management in Pharmaceuticals, Chemical, Petrochemical, Food Processing/Manufacturing or other highly regulated environment. Required Experience and Skills: A strong mechanical aptitude, Maintenance, field engineer, project engineer or supervisor experience in chemical or manufacturing environments, History interacting with skilled trades (e.g. Piping, Electrical, Millwrights, Instrumentation, 3rd party contractors and vendors), Ability to read and understand P&IDs and technical/mechanical diagrams, Familiarity with Change Management and Compliance processes and principles, Excellent organizational skills with an ability to multi-task, Effective interpersonal and communication skills, both verbal and written, A collaborative mindset, Desire and willingness to learn, contribute and lead, Track-record of independent problem-solving, and Fluent in Microsoft Office, use of email. Desired Experience and Skills: Prior history of managing a 3rd party contract management/safety process, Maintenance experience in Good Manufacturing Practice pilot plants or manufacturing environments, Experience with coordinating maintenance activities around processing activities to support reliable facility operation, Familiarity with US and EU Safety and Good Manufacturing Practice compliance regulations, OSHA 10 (General Industry or Construction) or higher Experience with Potent Compound processing and containment systems (e.g., isolators), or clean room facilities, Experience operating/maintaining pilot scale or prep lab scale equipment, Experience with Good Manufacturing Practice facility design, equipment start-up and/or qualification, Experience with high-risk work including, but not limited to, Lockout/Tagout, Hazardous Energy Control, Elevated Work, and Confined Space Entry, Experience with Electrical Classifications for solvent and dust (Class I and II, Div I and II), Experience with preparing Standard Operating Procedures (SOP) and Good Manufacturing Practice documents, Trained in use of Hexagon for Plant Maintenance management and SAP for financial transactions, and Experience working in an environment with an Automation System (DeltaV, PLC, etc.). EligibleforERP Required Skills: cGMP Guidelines, Contractor Management, Equipment Calibrations, Facility Operations, Lockout Tagout, Maintenance Management Systems, Material Sourcing, Microsoft Office, Pilot Plant Operations, Preventive Maintenance, Process Equipment, Project Engineering, Safety