|Job Description Primary Role:
Position requires experience in large scale cell culture production facilities. Specific experience in cell cultivation, bioreactor operations, centrifugation, clarification, roller bottle operations is preferred. In addition experience with disposable technology and aseptic processing is a plus.
Responsibilities include trouble shooting, determining root cause of problems and providing optimization strategies for process equipment within a multi-product, FDA regulated, cGMP facility. The candidate will ensure that a large number of highly complex pieces of process equipment and systems remain within their validated state and regulatory compliance.
Candidate will serve as a consultant to management on major engineering challenges pertaining to policies, plans, and objectives. Candidate will be a prime contact to Manufacturing and Facility clients and external engineering and vendor resources in the conceptual design, detailed design, specification, procurement, construction, and commissioning of process equipment for cGMP production facilities. All system improvements will be made in conjunction with Manufacturing, Facilities, Manufacturing Technical Services, Quality Assurance, Validation and Regulatory. Candidate will be asked to develop solutions to a variety of complex problems which require the regular use of ingenuity and innovation.
Must be able to work in a fast-paced multi-disciplinary environment.
% of Time Job Duty and Description
Operational support (35%)
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
Represent site on Safety Steering Committee
On call support 24/7
Small Project Support (cross-site in scope)(30%)
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, QHRs, 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
May act as project manager for small process equipment projects
Tech Transfer, Operational Excellence (OE) and Disposables Support (20%)
Point of contact for Process Development/Manufacturing Technical Services in tech
Utilize/Develop Equipment List (URS Data, Equipment Data Sheet Data, CTP Data) to pick
site and make equipment decisions for new technologies
Dept expert in OE tools and philosophy
Point person for OE projects
Create process for purchasing and maintaining disposable components
Re-engineer current disposable components as needed
Standards and Templates (10%)
Develop engineering standard practices that will result in consistent, reproducible
Creates templates to be used at all sites for URS/FS/DDS
Identifies equipment specific best practices and performs gap analysis between Shire and
Keep abreast of advancement in new technologies
Develop / Improve Commissioning Guidelines and Templates
Large Project Support (5%)
Provide project team with 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
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 with their role on large projects
Education and Experience Requirements:
Required education: Bachelors degree in Chemical or Mechanical Engineering.
Minimum 5-8 years experience in a cGMP Engineering environment
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 & 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 FATs and external commissioning. Travel may include international travel
Travel should not exceed 20%
|Shire Human Genetics Therapies|
State or Province