Sr Plant Engineer II

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.

Essential Functions:

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
- 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 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 requirements
- 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
- Owns and ensures timely closure of equipment related CAPAs and Change Controls

Education & Experience Requirements:

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

Key Skills and Competencies:

- Effective verbal and written communication skills
- Excellent interpersonal and teamwork skills required
- Adherence to domestic and international GMP regulations
- Ability to multi-task in a dynamic environment with changing priorities
- Proficiency with Microsoft products; ability to learn additional software applications, as the need arises - TrackWise experience a plus.

Complexity and Problem Solving:

- Individual must be capable of performing assignments that have loosely defined objectives that require investigation of a large number of variables.
- Can function as a technical expert to equipment and systems regarding troubleshooting and operations.
- Ability to apply diversified knowledge of engineering principles and practices to a broad variety of assignments and related fields.
- Work with cross-functional groups in developing requirements and recommendations for highly complex system/facility modifications.
- Works on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors.
- Exercises judgment in selecting methods, techniques and evaluation criteria for obtaining results.
- Contributes to the development of new concepts, techniques, and standards.
- Considered expert in field within the organization.
- Work is performed without appreciable direction.
- Exercises considerable latitude in determining objectives and approaches to assignment.
- Effects of decisions are long-lasting and heavily influence the future course of the organization

Internal and External Contacts:

- In addition to working closely with members of the ETS Group and external Engineering resources, this individual will have regular contact with Manufacturing and Facility clients.
- The candidate must be able to integrate the Validation and Quality department requirements into all aspects of the daily routine.
- Networks with key contacts outside own area of expertise.
- Serves as consultant to management and special external spokesperson for the organization on major matters pertaining to its policies, plans, and objectives.

Other Job Requirements:

- Ability to work at all Shire MA locations (Cambridge and Lexington)
- Expected to carry Blackberry device for on-call 24 hour support as required
- Travel is currently limited to vendor visits including FAT's and external commissioning. Travel may include international travel
- Travel should not exceed 20%