Responsibilities:
- Provide engineering and technical support for manufacturing execution systems (MES) in biopharmaceutical operations; evaluate/develop technology and plan/implement modifications.
- Provide technical leadership and support for MES (Emerson Syncade and InfoLog) and network infrastructure, including electronic batch records, ensuring business continuity and compliance.
- Collaborate with stakeholders across the automation lifecycle: gather system/end user requirements; complete design, implementation, and testing/validation; maintain documentation; maintain/monitor systems.
- Own and support MES deployments and associated systems.
- Plan/prioritize/manage execution system updates driven by process changes, audits, and CAPA actions.
- Troubleshoot and resolve real-time operational issues (including night shift troubleshooting), diagnosing MES problems and developing/executing solutions.
- Support visualization and accessibility of aggregate data using PowerBI, InfoBatch, and SQL.
- Support regulatory inspections by representing MES systems; provide user support for technical issues.
- Adhere to and continuously improve operation/maintenance procedures for MES.
- Support OT environment upkeep via administration of systems, networks, databases, and accounts (servers/hosts/analytical equipment).
- Support systems integration and digital transformation initiatives; stay current with controls and MES developments.
Qualifications:
- BS/BA in engineering, life sciences, biology, or equivalent technical discipline.
- 4+ yearsβ experience designing, programming, start-up, and troubleshooting MES (Syncade).
Preferred Skills/Experience:
- Diagnose problems, generate options, prioritize, select optimal solutions, and implement/resolution.
- Experience with systems/account administration, network design, and server troubleshooting.
- Coding experience in Visual Basic or similar languages.
- GMP experience.
- Experience with PLC (Allen Bradley) and/or DCS (DeltaV).
- Knowledge of current control system platform standards and computer system validation.