Specialist, Engineering (Onsite)

Job description

Job Description The Formulation, Laboratory, and Experimentation (FLEx) Center in Rahway, New Jersey, features a cutting-edge sterile drug product cGMP clinical supply manufacturing facility, known as FLEx Sterile. The FLEx Sterile 2 facility expansion is a strategic capital project designed to significantly enhance clinical supply manufacturing capacity by adding a second sterile filling and lyophilization suite, a formulation suite, a sterile supply suite, and supporting infrastructure and utilities. The Durham, North Carolina site is a commercial vaccine manufacturing facility with drug substance, drug product, and sterile supply manufacturing operations, and supporting infrastructure and utilities. The Specialist Engineer position will initially be based in Durham, NC for approximately 12 to 18 months to support business needs. After completion of this initial 12-to-18-month period, the role will relocate to Rahway, NJ based on business needs. This location change will not be considered a “termination of employment due to a restructuring” as defined in the company's US Employee Separation Benefit Plan. The role will require on-site support. Durham Site The 12 to 18 month rotation at the Durham, NC site will allow the Specialist Engineer to gain experience supporting commercial drug product manufacturing operations including formulation, filling, lyophilization, and visual inspection. Responsibilities at the Durham site will be based on business needs and may include but are not limited to shop floor equipment and automation troubleshooting, deviation investigation support, change controls, equipment validation, technical protocol authoring and execution, and equipment maintenance. Rahway Site FLEx 2 is a strategic expansion that will increase sterile clinical manufacturing capacity through additional filling, lyophilization, formulation, and supporting utility suites. These roles provide technical support across formulation, process development, manufacturing, equipment, and automation to ensure GMP compliance, operational readiness, and efficient, reliable sterile drug product operations. Technical Operations (FLEx Tech Ops) Serve as technical SME for formulation, process development, and scale-up activities. Support manufacturing by authoring quality investigations, change controls, SOPs, and technical protocols required to support clinical drug product operations. Contribute the execution of the commissioning, qualification, and regulatory certification of the FLEx Sterile GMP Clinical Manufacturing facility. Collaborate closely with the formulation scientists, engineers, quality representatives, and other team members to ensure the quality of the clinical supplies, the scientific rigor of the processes, and ultimately to enable the flexibility and speed of our Company's pipeline. Work with a variety of state-of-the-art aseptic drug product formulation, filling, and lyophilization equipment while completing processes throughout the manufacturing cycle Manage individual project assignments and aid in facility and process equipment innovation. Perform manual and/or automated operations, general maintenance, troubleshooting and support functions Pharm Ops Engineering (POE) - Equipment Serve as a technical SME for equipment troubleshooting, maintenance, and coordination with engineering, utilities, facilities, OEM vendors, and contractors. Support Quality Engineering and capital projects, including equipment installation, commissioning, validation, and lifecycle management. Lead sterilization and cleaning validation programs by authoring and reviewing validation documents, coordinating execution activities, conducting technical assessments, and supporting regulatory inspections as a validation SME. Own change management, periodic reviews, deviation investigations, root cause analyses, and CAPA implementation while maintaining GMP documentation. Maintain GMP-compliant facilities, utilities, and manufacturing equipment using reliability maintenance practices, tracking calibrations and PMs, and assisting with shutdown planning and execution. Manage operational and administrative activities including work order oversight, contractor coordination, purchase orders, budgets, asset tracking, and project closeout activities. Pharm Ops Engineering (POE) - Automation Maintain validated and compliant automation systems for sterile manufacturing, ensuring adherence to GMP, data integrity, cybersecurity, and lifecycle management requirements. Provide automation support for formulation, filling, and lyophilization operations, including troubleshooting, root cause analysis, reliability improvements, and on-floor manufacturing support. Lead automation change management, investigations, CAPAs, periodic reviews, and regulatory inspection readiness while maintaining automation documentation and system configurations. Support capital projects and new product introductions by leading automation design, integration, FAT/SAT, commissioning, qualification (AIOQ), and acceptance testing activities. Manage automation system strategy and lifecycle planning, including upgrades, expansions, obsolescence remediation, OT/IT architecture, cybersecurity, backups, and disaster recovery. Develop data, reporting, and visualization solutions while collaborating with manufacturing, quality, facilities, engineering, IT, and external vendors to drive operational excellence and continuous improvement. Education Minimum Requirements B.S. Degree in Chemical/Bio-Chemical Engineering or Chemistry/Biological Sciences or related disciplines. with a minimum of 2 years of relevant experience. Required Experience and Skills: Familiarity with United States and European Union GMP and safety compliance regulations. Strong problem-solving skills and ability to work independently. Strong organizational skills with the ability to manage multiple priorities and deadlines. Ability to collaborate effectively with cross-functional teams and stakeholders. Excellent verbal and written communication skills. Preferred Experience and skills: Project management Cross functional leadership Change Control Deviation Management Strong technical writing Sterile process manufacturing, sterile drug product and/or formulation development #eligibleforERP #PSCS FLEx2026 Sterile2026 Required Skills: Electronic Batch Records, Equipment Maintenance, Operation Maintenance, Pilot Plant Operations, Process Engineering, Process Manufacturing, Product Formulation, Root Cause Identification, Sterile Manufacturing, Troubleshooting Preferred Skills: Clinical Manufacturing, Drug Product Manufacturing, Manufacturing Operations 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