Associate Specialist, Engineering; Onsite

Job Description

The Formulation, Laboratory, and Experimentation (FLEx) Center in Rahway, New Jersey, includes a cutting‑edge sterile drug product cGMP clinical supply manufacturing facility, known as FLEx Sterile, which is currently in the operational start‑up phase. FLEx Sterile is positioned to play a pivotal role in delivering our clinical pipeline to patients worldwide, supporting a diverse range of product modalities including sterile small molecules, biologics, vaccines, and antibody‑drug conjugates (ADCs).

The facility supports the formulation and filling of clinical and developmental sterile products for critical program needs, such as new products in process development, products undergoing scale‑up, launch and transfer to the supply network, and existing commercial products undergoing process optimization. Support encompasses both start‑up operations (FLEx Sterile1) and a new capital build (FLEx Sterile2).

• Work closely with divisional/enterprise Information teams, global infrastructure, and risk/security organizations to ensure that project deliverables and ongoing operations receive appropriate support.
• Support the successful implementation of automation solutions, including both platform technologies and associated reporting needs.
• Execute / develop appropriate system validation, change control and user test acceptance documents (UAT).
• Lead/participate in installation, integration, FAT/SAT, commissioning, and qualification of new automated equipment and systems for new capital project line (FLEx sterile
  2); author/execute URS/RS/CS/DS/AIOQ/UAT.
• Support a suite of reporting, analytics and visualization solutions that support local clinical operations and administrative business processes.
• Maintain automation systems in a validated state, as part of an active/ongoing lifecycle management program and in compliance with Current Good Manufacturing Practices.
• Implement system changes and conduct system investigations.
• Active and engaged participation in the site tier processes (routine operations support processes) as well as supporting a culture of continuous improvement at the site.
• Troubleshoot challenging equipment/automation issues to improve equipment/automation system performance to support PSIM readiness.
• Provide support as a representative on a startup or existing production team providing technical assistance in fulfilling the automation requirements for the team.
• Review automation documents, preventive maintenance, and Standard Operating Procedures to ensure compliance with Good Manufacturing Practice and safety.
• Support and execute corrective actions for investigations related to automation/OT or IT systems.
• Develop and maintain automation and computer system validation specific standard operating procedures (SOPs).
• Perform automation system periodic reviews (PR) and system user annual reviews.
• Develop technical knowledge to assure the efficient operation of a variety of automated processing and operational and informational technology systems.
• Provide on‑floor support of clinical manufacturing activities.
• Provide client services support for business area applications.
• Off‑shifts (second shift/weekend) or extended shift work may be required to provide automation support for manufacturing operations.

• BS in Engineering science, computer science, or Information system

• Knowledge of cGMP, Quality Systems, Safety, Environmental, data integrity, and validation principles for automation and computer systems.
• Basic understanding of PLC/SCADA and industrial networking fundamentals; ability to troubleshoot across controls, instrumentation, electrical, and software layers.
• Strong interpersonal, communication, and technical writing skills; ability to lead without authority and influence cross‑functional teams.
• Proven root cause analysis and problem‑solving skills; continuous improvement mindset.
• Strong technical writing capabilities.
• Effective communication and interpersonal skills to interface effectively with all levels of colleagues in a team environment, and with external customers and vendors.