Senior Plant Engineer

Primary Role:

Responsible for overall performance and monitoring of process and plant utility systems.
Responsible for utility equipment design and commissioning on capital projects.
Provides in-house engineering expertise to the maintenance staff.

Position requires experience with clean utilities (WFI, Purified Water, Clean Steam and Compressed Air) and plant utilities (Plant Steam, Chilled Water, HVAC, electrical and condensate systems).

Responsibilities include trouble shooting, determining root cause of problems and providing optimization strategies for utility equipment within a multi-product, FDA regulated, cGMP facility. The candidate will ensure that utility systems remain within their validated state and regulatory compliance.

Candidate will be the primary liaison between Manufacturing and Facility clients and external engineering and vendor resources in the conceptual design, detailed design, specification, procurement, construction, and commissioning of utility equipment for cGMP production facilities. All system improvements will be made in conjunction with Manufacturing, Facilities, Manufacturing Technical Services, Quality Assurance, Validation and Regulatory.

Must be able to work in a fast-paced multi-disciplinary environment.

Responsibilities:

30% - Operational support
- Troubleshooting support for complex process equipment problems as elevated by Eng I /II
- Serves as subject matter expert to close out Quality Systems
- Serves as subject matter expert for Regulatory filings
- On call support 24/7
30% - Large Project Support
- Provide project team with utility system engineering design requirements
- Provide budgetary and schedule estimates for the requirements of projects
- Communicate project requirements to vendors to obtain proposals for equipment and piping changes
- Execute JHA/PHA reviews on all new projects/equipment
- Develop and execute engineering tests, FATs, SATs and commissioning test plans
- Train operations staff on new/ revised operating procedures
- Pre/Post approve validation protocols
- Troubleshoot and remediate exceptions found during IQ/OQ/PQ
- Develop engineering project documentation
- May assist project manager or act as project manager for small utility projects
10% - Standards and Templates
- Develop engineering standard practices that will result in consistent, reproducible documents site-to-site
- Creates templates to be used at all sites for URS/FS/DDS
- Identifies equipment specific best practices and performs gap analysis between Shire and best practice
- Keep abreast of advancement in new technologies
- Develop / Improve Commissioning Guidelines and Templates
10% - Tech Transfer, Operational Excellence (OE)
- Point of contact for Process Development/Manufacturing Technical Services in tech transfer projects relating to utility projects.
- Utilize/Develop Equipment List (URS Data, Equipment Data Sheet Data, CTP Data) to pick site and make equipment decisions for new technologies
- Project commissioning/ICV
20% - Small Project Support (cross-site in scope)
- Accountable for all phases of the Change Control process for owned changes
- Owns and ensures timely closure of equipment related CAPAs
- Provide and/or ensure generation of all supporting documentation (scope documents; approval slides; work orders; protocols)
- Use project management skills to schedule, track progress, and make adjustments
- Defines all aspects of project scope
- Uses appropriate business / quality systems such as Trackwise, Datastream, QHR's, etc.
- Knowledge of how small projects to tie in to other sites.
- Provide peer review for all QA and Engr documentation

Education & Experience Requirements:

- Required education:
Bachelors degree in Chemical or Mechanical Engineering
- Minimum 5-8 years experience with clean and plant utility systems
- Minimum 5+ years experience in equipment design and oversight of fabrication