The Senior Process Project Engineer I will provide project support to upstream and downstream areas (equipment/systems) in the manufacturing of commercial and clinical products at Takeda MA sites. The Process Engineering function covers all equipment and systems related to:
- Vial Thaw / Cell Expansion
- Bioreactor operations,
- roller bottle operations
- Single Use
- Ultrafiltration / Diafiltration Systems
- Chromatography Systems
- Filtration Systems
- Viral Filtration/Inactivation Systems
- Buffer solution preparation
- Clean-in-place skids and cycles
- Clean-out-of-place washers, glass washers
- Steam-in-place cycles
- Autoclaves and cycle development
- Filter integrity testing
- Central caustic distribution systems
- Bench top process analytics and technology
- Good engineering practices (procedures and standards for engineering lifecycle covering requirements, specification & design, verification, acceptance & release)
- Project engineering activities associated with technology transfers (feasibility, facility fit assessment, user requirements, process description, change control ownership, commissioning test plans, training)
The Senior Process Project Engineer I will be part of a dynamic group of engineers who will be responsible for trouble shooting, determining root cause of problems, identifying change requirements and implementing projects for process equipment within multi-product, FDA regulated cGMP facilities. 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 be the primary liaison between Manufacturing, Facilities, 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, Process Development Technical Services, Quality Assurance, Validation and Regulatory.
Must be able to work in a fast-paced multi-disciplinary environment.
40% of Time: Small Project Support (cross-site in scope)
- Accountable for all phases of the engineering change management process and change control support 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, Veeva, Datastream, etc.
- Provide peer review for all QA and Engineering documentation
- Act as project manager for small process equipment projects
40% of Time: Large Project Support (cross-site in scope)
- Provide project team with engineering design requirements
- Provide budgetary and schedule estimates for the requirements of projects
- Develop and support any feasibility studies or engineering tests required to define project scope.
- Communicate project requirements to vendors to obtain proposals for equipment and piping changes
- Execute JHA/PHA reviews on all new projects/equipment
- Perform EHS management of change and HAZOP documentation as required
- 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 with their role on large projects
10% of Time: Engineering best practices and technologies
- Identifies equipment specific best practices and performs gap analysis between Shire and best practice
- Keep abreast of advancement in new technologies
10% of Time: Operational Support
- Troubleshooting support for complex equipment and process problems as elevated by Eng I/II
- Serves as subject matter expert for designated process systems
- Serves as subject matter expert for close out of Quality Systems and Regulatory filings
- Interface with manufacturing management to highlight operational project priorities and communicate with priorities with junior engineers
- On call support 24/7
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, Abilities, and Competencies
- Effective verbal and written communication skills
- Excellent interpersonal and teamwork skills required to work effectively and efficiently in a team-based environment
- 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 and GE UNICORN experience a plus.
- Continuously increases job knowledge and proficiency related to engineering in the biopharmaceutical industry, as well as technical understanding/problem solving capability.
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.
- Work on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors.
- Demonstrates good judgment in selecting methods, technique, and evaluation criteria for obtaining results.
- Contributes to the development of new concepts, techniques, and standards.
- Complete understanding and application of engineering principles, concepts, practices, and standards.
- Work is performed under general direction.
- Participates in determining objectives of assignment.
- Plan schedules and arranges own activities in accomplishing objectives.
- Work is reviewed upon completion for adequacy in meeting objectives.
- Exerts some influence on the overall objectives and long-range goals of the organization.
Internal and External Contacts
- Internal contacts include those in the Facilities & Engineering, Validation, Quality, Manufacturing, Process Development Technical Services, and Project Management groups.
- External contacts include service suppliers, vendors, industry peers and industry groups.
- May interact directly with regulators during inspections.
Other Job Requirements
- Ability to work in a fast-paced environment and handle multiple tasks simultaneously.
- The ability to travel and work at all Shire facilities.
- Candidate will be required to carry a cellular device and be available to support requirements at all sites.
- May be required to travel for business reasons (e.g. training, meetings).
Notice to Employment / Recruitment Agents:
Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire, a wholly-owned subsidiary of Takeda s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire, a wholly-owned subsidiary of Takeda will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire, a wholly-owned subsidiary of Takeda and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.
Equal Employment Opportunity
Shire, a wholly-owned subsidiary of Takeda, is an Equal Opportunity Employer committed to a diverse workforce. Shire, a wholly-owned subsidiary of Takeda, will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.
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Shire, a wholly-owned subsidiary of Takeda, is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.