Facility Engineer, MACS Senior Specialist (On-site)

Job description

Job Description Description: 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 technical, mechanical, and project management responsibility. The Facility Engineer position will report to the Associate Director, Engineering and will be a member of the Equipment Development and Facility Engineering team. 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, troubleshooting and continuous improvement of equipment. Responsibilities: This role at the Sr. Specialist level will serve as a technical mentor and process team member supporting the Modality Agnostic Chemistry Scaleup Center. This is a new potent, multi-modality (small molecule, macrocyclic peptides, bioconjugates) Drug Substance development and Good Manufacturing Practice clinical manufacturing plant currently under construction. As the Modality Agnostic Chemistry Scaleup Center is nearing construction completion, the selected candidate 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. The selected candidate is expected to foster a culture of collaboration, learning and innovation within Enabling Facilities, the Modality Agnostic Chemistry Scaleup Capital Project and Modality Agnostic Chemistry Scaleup Operations. After the facility starts up, they will collaborate closely with Enabling Facilities and Modality Agnostic Chemistry Scaleup Operations team members, development engineers & chemists, and compliance representatives, to ensure the quality and safe delivery of clinical supplies, the availability and reliability of facilities, the scientific rigor of the processes and ultimately enable flexibility and speed in the Company’s pipeline. Additional Supported Areas: The Sr. 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 Process 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. Minimum Requirements: Required Education: Bachelor of Science degree in an Engineering or related scientific field with minimum of 6 years relevant experience, or Master’s degree with 5 years of relevant experience, or PhD degree with 2 years of relevant experience Required Experience and Skills: Experience with Good Manufacturing Practice facility design and equipment start-up and/or qualification. Strong mechanical aptitude. Ability to read and understand P&IDs. Familiarity with Electrical Classifications for solvent and dust (Class I and II, Div I and II). Experience in Process Hazard Analysis (PHA) and/or Level of Protection Analysis (LOPA) Experience interacting with skilled mechanical tradesmen and construction management organizations. Experience operating/maintaining manufacturing, pilot scale or prep lab scale equipment. Experience in supporting compliance investigations and change management. Familiarity with US and EU Good Manufacturing Practice and Safety compliance regulations Familiarity with Change Management processes and principles. Ability to comprehend and/or prepare Standard Operating Procedures and Good Manufacturing Practice documents. Fluent in Microsoft Office, use of email, and meeting facilitation. Effective interpersonal and communication skills, both verbal and written. Sound decision-making skills, knowing when to escalate vs. taking action, and ability to explain rationale for decisions. Excellent organizational skills to multi-task. Desire and willingness to learn, contribute and lead. Track-record of independent problem-solving. Desired Experience and Skills: Experience in capital projects, specifically as the end-user Experience providing technical mentorship. Experience with Potent Compound processing and containment 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 with coordinating maintenance activities around processing activities to support reliable facility operation. Experience with Process Analytical Technology. Experience with development of new instrumentation technologies. Trained in use of Hexagon for Plant Maintenance management and SAP for financial transactions. EligibleforERP Required Skills: Asset Management, Automation Systems, Equipment Qualification, Facility Design, Facility Engineering, Facility Operations, Good Manufacturing Practices (GMP), Hazard Analysis, Maintenance Strategy, Mentorship, Process Hazard Analysis (PHA), Process Optimization, Project Closeout, Root Cause Analysis (RCA), Technical Problem-Solving 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.  As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.  For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement​ We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts The primary location for this posting is: USA - New Jersey - Rahway Where requ