Senior Specialist, Engineering; Onsite

Position: Senior Specialist, Engineering (Onsite)
* 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.
* Off‑shifts (second shift/weekend) or extended shift work may be required to provide automation support for manufacturing operations.
* 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
* 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.
* 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…