Specialist Mechanical Coordinator

Job Description

The Enabling Facilities (EF) group within the Chemical Engineering Research & Development (CERD) Department is seeking a highly motivated individual to work in a fastpaced job that provides a high degree of practical technical mechanical and planning responsibility. The Equipment Development and Facility Engineering (EDFE) Mechanical Coordinator position will report to the Associate Director Engineering and will be a member of the MACS EF Team at the Rahway NJ facility. EF is responsible for development of new technologies/capabilities of capital and noncapital improvement projects and the automation system assets spanning production utility systems and associated infrastructure. EDFEs role within EF includes design installation qualification startup maintenance and troubleshooting of equipment and systems.

Responsibilities of the MACS EDFE Mechanical Coordinator include the following:

The Mechanical Coordinator role at the Specialist level will serve as a team member supporting the Modality Agnostic Chemistry Scaleup (MACS) Center. This is a new potent multimodality (small molecule macrocyclic peptides bioconjugates) Drug Substance development and GMP clinical manufacturing plant currently planned in Rahway New Jersey. The Specialist will serve as a valued team member during the MACS Center Phase and will support the facilitys operations after startup.

As the facility is currently under construction the selected candidate will contribute to equipment and facility design system commissioning/qualification and operational readiness planning to enable facility startup. Upon startup the selected candidate will lead the daily mechanical activities and be responsible for the planning and supervision of maintenance improvement and yearly shutdown/turnaround efforts. It will involve learning understanding and applying the maintenance requirements and safe work practices in effect at the Rahway site to prepare the facility and its equipment for a multidiscipline team of internal tradesmen and 3rd party contractors to execute said maintenance and improvement activities.

Daily activities include:

• Prioritization of mechanical work to meet the timelines of the business

• Hazardous permits including line breaks Class A & B hot work elevated roof and confined space entry.

• Lockout/Tagout and Energy Control Procedure implementation and development

• Emergency Repairs/Troubleshooting

• Calibration/Routine Preventative Maintenance

• Process Equipment setup and requalifications

• Design of small facility modifications

• Materials sourcing and procurement

• Interaction with Computerized Maintenance Management System (CMMS) applications

The candidate will 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 in a very dynamic production environment the readiness of maintenance work and will adjust priorities of the work on an ongoing basis which ultimately will contribute to the flexibility and speed of the Companys pipeline.

Education Minimum Requirement:

• High School Diploma/GED plus at least four 4 years of relevant experience in Pharmaceutical Chemical Petrochemical or Food Processing/Manufacturing.

Required Experience and Skills

• A strong mechanical aptitude

• Maintenance experience in manufacturing environments

• History interacting with skilled trades (Piping Electrical Millwrights Instrumentation 3rd party contractors and vendors)

• Ability to read and understand P&IDs and technical/mechanical diagrams

• Familiarity with Change Management processes and principles

• Excellent organizational skills with an ability to multitask

• Effective interpersonal and communication skills both verbal and written

• A collaborative mindset

• Desire and willingness to learn contribute and lead

• Trackrecord of independent problemsolving

• Fluent in Microsoft Office use of email.

Desired Experience and Skills:

• Maintenance experience in GMP pilot plants or manufacturing environments

• Familiarity with US and EU Safety and GMP compliance regulations

• 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 coordinating maintenance activities around processing activities to support reliable facility operation.

• Experience with GMP facility design equipment startup and/or qualification.

• Experience with highrisk 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 cGMP documents.

• Trained in use of SAP for Plant Maintenance management.

• Experience working in an environment with an Automation System (DeltaV PLC etc..

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Effective September 5 2023 employees in officebased positions in the U.S. will be working a Hybrid work consisting of three total days onsite per week Monday Thursday although the specific days may vary by site or organization with Friday designated as a remoteworking day unless business critical tasks require an onsite Hybrid work model does not apply to and daily inperson attendance is required for fieldbased positions; facilitybased manufacturingbased or researchbased positions where the work to be performed is located at a Company site; positions covered by a collectivebargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note this Hybrid work model guidance also does not apply to roles that have been designated as remote.

The Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Final determinations with respect to salary will take into account a number of factors which may include but not be limited to the primary work location and the chosen candidates relevant skills experience and education.

Expected US salary range:

Available benefits include bonus eligibility long term incentive if applicable health care and other insurance benefits (for employee and family) retirement benefits paid holidays vacation and sick days. A summary of benefits is listed here.

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