Associate Specialist, Engineering; Onsite

Position: Associate Specialist, Engineering (Onsite)
* 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.
* 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.
* Platforms/technologies:
Allen-Bradley and/or Siemens PLCs; SCADA (iFix, WinCC OA, Ignition); OPC; field buses (ASI/Profibus/Profinet/Device Net); 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 plus.
* OT/IT:
Industrial networking, virtualization (e.g., VMs), databases/historians, and basic system administration
* Demonstrate a strong performance record
* Highly developed communication and teamwork skills
* Track record of independent ownership, prioritization, and delivery in a fast-paced clinical manufacturing setting
* Direct impact enabling sterile product development from lab to clinic through robust, compliant automation
* Ownership across automation lifecycle, troubleshooting, and capital initiatives
* Collaboration with world-class operations, quality, engineering, IT, and security teams
** Los Angeles Residents Only:
** We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance
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