Associate Specialist, Engineering – Automation (Onsite)

Job Description

Job Description:

 The Formulation, Laboratory, and Experimentation (FLEx) Center in Rahway, New Jersey, includes a cutting-edge drug product cGMP clinical supply manufacturing facility, known as FLEx Non-Sterile. The FLEx facility supports the formulation and filling of clinical, stability, and developmental supplies for Oral Solid Dosage (OSD) and Inhalation products, including critical program needs related to new products undergoing process development, new products undergoing scale-up, launch and transfer to the supply network and existing commercial products undergoing process optimization.

The Associate Specialist, Engineering – Automation role will provide end-to-end automation engineering support for the Rahway, NJ FLEx Center, with a primary focus on non-sterile clinical manufacturing within Pharmaceutical Sciences and Clinical Supply (PSCS), Pharmaceutical Operations Engineering (Pharm Ops Engineering). This role ensures the reliable and compliant operation of process automation and OT/IT systems that enable activities for clinical and development non-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 Non-Sterile Pharmaceutical Operations Engineering automation lead.

Primary Responsibilities:

• 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 projects; 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.

Education Minimum Requirement: 

• BS in Engineering, computer science, or Information system or 1 years of relevant industry experience.

• Strong technical writing capabilities.

• Effective communication and interpersonal skills to interface effectively with all levels of colleagues in a team environment, and with exter