Job Description:
Senior level technical individual contributor on the Process Automation Team within the Devens Cell Therapy Facility. Responsible for complex tasks with minor guidance. Maintain, configure, administer, and troubleshoot Aveva PI Systems. Provide support for DeltaV and BAS systems.
Responsibilities:
- Subject matter expert for Aveva PI and Data Historian Systems.
- Lead complex technical efforts (large scope changes, difficult integrations).
- Integrate with cross-functional teams to perform qualification and validation.
- Support audits as a front room representative.
- Knowledgeable of DeltaV, Syncade, and other manufacturing systems.
Required:
- 4+ years experience with Aveva PI (PI Data Archive, PI Asset Framework, PI Vision).
- Experience designing and implementing data system interfaces/integrations.
- Deep understanding of 21CFR11 and Data Integrity principles.
- Experience working with enterprise and local teams.
- Validation Lifecycle Management experience (planning, IQ/OQ/PQ execution).
- Experience with SQL, Server, Oracle, or other relational databases.
- QMS systems experience (Veeva or similar) and GMP Quality Processes (Deviation Management, Change Controls, etc.).
- Ability to troubleshoot network/control/data systems from field element through operator interfaces and databases.
- Experience with IT ticketing systems (ServiceNow or similar).
- Excellent oral/written communication and formal presentation skills; can communicate technical information to varied audiences.
Preferred:
- Control system networking and PC networking technologies.
- S88, S95, batch processing.
- Engineering documentation knowledge (P&IDs, network diagrams, process flow diagrams, SOPs).
- DeltaV, Syncade (or equivalent) experience.
- Validation Lifecycle Management systems (Valgenesis or similar).
- Building Automation Systems.
- .Net scripting.
Education/Experience:
- Bachelorβs degree in engineering or equivalent.
- 4β6 years experience working with Aveva PI.
- 2+ years experience with control systems (DeltaV, BAS, PLCs) in pharmaceutical/biotechnology.
Compensation:
Devens, MA, US: $108,650 - $131,655.
Application instructions:
If you come across a role that intrigues you but doesnβt perfectly line up with your resume, apply anyway.