Job Description

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 various 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).

The Senior Specialist, Automation Engineering will provide end-to-end automation engineering support for the Rahway, NJ FLEx Center, with a primary focus on sterile clinical manufacturing within Pharmaceutical Sciences and Clinical Supply (PSCS), Pharmaceutical Operations Engineering (Pharm Ops Engineering). The role ensures the reliable and compliant operation of process automation and OT/IT systems that enable formulation, filling, lyophilization, and associated support activities for clinical and development sterile products. This position supports start-up operations and new capital investments in the clinical supply area, including automation lifecycle management, data and analytics, and site representation on capital projects. Off-shift (second shift and weekend) or extended shift work will be required on an intermittent basis to support manufacturing operations. This role will be an onsite automation support role and directly reports to the Rahway FLEx Sterile Pharmaceutical Operations Engineering automation lead.

Primary Responsibilities:

• Maintain automation systems in a validated, compliant state per cGMP, Safety, data integrity, cybersecurity, and lifecycle best practices (commissioning, qualification, change control, obsolescence, periodic reviews)

• Provide end-to-end operations support for sterile clinical manufacturing (formulation and filling/lyophilization), including on-floor troubleshooting, root cause analysis, and performance/batch reliability improvements

• Implement and sustain platform automation solutions, reporting, and visualization to meet operational and compliance needs; keep documentation, SOPs, drawings, configurations, PMs, and inventories inspection ready.

• Lead and participate in automation system changes, investigations, CAPAs; represent automation and data integrity during internal/external audits and inspections.

• Develop and execute automation change control inclusive of change definition, risk assessments, impact assessments, task execution, implementation, and support of associated regulatory filings.

• Serve as site automation representative for new products, process changes, and operational improvements; lead cross-functional teams and participate in tier meetings to drive continuous improvement.

• Represent automation in capital projects, embedding OT/IT architecture, cybersecurity, data integrity, and validation requirements in project scope and deliverables.

• Lead and coordinate installation, integration, FAT/SAT, commissioning, and qualification (AIOQ) of new automated equipment and systems; author/execute URS/RS/CS/DS/AIQ/AOQ/AIOQ/UAT.

• Evaluate and plan automation/IT expansions, replacements, upgrades, and obsolescence remediation to ensure quality, stability, scalability, and supportability.

• Partner with enterprise/divisional IT, global infrastructure, and risk/security to align standards and manage user/role administration, patching, backups, disaster recovery, and virtualization in GMP operations.

• Collaborate with GES, FM/GWES, Quality (product/equipment QA and digital data quality -DDQ), Manufacturing Operations, OEM vendors/system integrators to deliver reliable, compliant automation operations.

• Supervise and coordinate contract engineers/vendors and manage workload and deliverables.

• Develop and support data, reporting, analytics, and visualization solutions using historian/SCADA sources to monitor asset health and drive reliability improvements.

• Troubleshoot across controls, instrumentation, electrical, software, and industrial networking layers; apply lean and continuous improvement principles to stabilize and optimize automation system performance.

• Offshifts (second shift/weekend) or extended shift work may be required to provide automation support for manufacturing operations.

Education Minimum Requirement:

• BS in Engineering, Science, or Information Systems, plus a minimum of 5 years of related technical support or manufacturing automation experience or acceptable related experience.

• Demonstrated a strong performance record and have excellent project management skills.

• Highly developed communication, leadership and teamwork skills

Required Experience and Skills:

• Strong knowledge of cGMP, Quality Systems, Safety, Environmental, data integrity, and validation principles for automation and computer systems.

• Hands-on experience maintaining validated automation systems, executing change control, investigations/CAPA, periodic reviews, system administration (e.g., user/role management, patching, backups, virtualization), and cybersecurity within GMP operations.

• Proficiency with 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.

Preferred Experience and Skills:

• Platforms/technologies: Allen-Bradley and/or Siemens PLCs; SCADA (iFix, WinCC OA, Ignition); OPC; fieldbuses (ASI/Profibus/Profinet/DeviceNet); instrumentation and panel design

• Programming: Ladder Logic, Sequential Function Charts, Python and/or other scripting for automation, testing, and reporting

• Knowledgeable of S88 batch standards.

• Experience in biologics, vaccine or bulk sterile manufacturing facilities is strongly preferred.

• OT/IT: Industrial networking, virtualization (e.g., VMs), databases/historians, and basic system administration

• Experience with electronic validation and quality systems (e.g., Kneat/eVal, Veeva)

• Prior leadership of installation/integration/qualification of automated equipment; experience on capital projects in GMP environments

• Familiarity with planning/scheduling practices, vendor management, and business/financial acumen for project delivery

• Track record of independent ownership, prioritization, and delivery in a fast-paced clinical manufacturing setting

• Demonstrated experience supporting audits/inspections and authoring/reviewing SOPs, validation protocols/reports.

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