The Process Engineer I will provide operational support to key process service areas (equipment/systems) in the manufacturing of commercial and clinical products at Shire MA sites.
The Process Services function covers all equipment and systems related to:
o Solution preparation (weigh and dispense, medias, buffers)
o Clean-in-place skids and cycles
o Clean-out-of-place washers, glass washers
o Steam-in-place cycles
o Autoclaves and cycle development
o Filter integrity testing
o Bench top process analytics and technology
o Good engineering practices (procedures and standards for engineering lifecycle covering requirements, specification & design, verification, acceptance & release)
o project engineering activities associated with technology transfers (feasibility, facility fit assessment, user requirements, process description, change control ownership, commissioning test plans, training)
The Process Engineer I will be part of a dynamic group of engineers who will be responsible for trouble shooting, determining root cause of problems and providing optimization strategies for process support 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 primarily interact with immediate supervisor and other personnel in the group on projects for Manufacturing and Facility clients 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, Product Development & Technical Support, Quality Assurance, Validation and Regulatory. Candidate will be asked to develop solutions to a variety of limited scope and complexity problems and follow standard practices and procedures to analyze solutions. Responsibilities
Operational Support - 60% of Time
- Primary point of contact for all equipment related troubleshooting, elevate to Sr Eng I/II as needed
- Owns and maintains the design and specifications for equipment and instrumentation.
- Serves as subject matter expert for cleaning (CIP/COP), sterilization, bioprocess analytics, single-use systems and support systems such as sterile tubing welders, filter integrity testers.
- Provide guidance to maintenance personnel and actively participates in the decision making process on equipment performance and design improvements.
- Provide technical input to manufacturing on SOP changes, deviations, and CAPAs.
- Execute WOs assigned by customer groups, as well as ones initiated by Engr, when they apply to daily plant support or troubleshooting
- On call support 24/7
Large Project Support - 10% of Time
- Assist in releasing system for operation Develop and support any feasibility studies or engineering tests required to define project scope.
- Develop and execute engineering tests, FATs, SATs and commissioning test plans
- Troubleshoot and remediate exceptions found during IQ/OQ/PQ
Engineering procedures, standards, and templates - 5% of Time
- Review and approve engineering standard practices as required - Limited focus, this will be secondary to operational support
Small Project Support (cross-site in scope) - 25% of Time
Education and Experience Requirements
- 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.
- Provide peer review for all QA and Engineering documentation
- May act as project manager for small process equipment projects
Key Skills, Abilities, and Competencies
- Required education: Bachelors degree in Chemical or Mechanical Engineering
- Minimum of 0-2 years experience in a cGMP Engineering environment working with process equipment
Complexity and Problem Solving
- 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 experience a plus.
- Continuously increases job knowledge and proficiency related to engineering in the biopharmaceutical industry, as well as technical understanding/problem solving capability.
Internal and External Contacts
- Work with cross-functional groups in developing requirements and recommendations for highly complex system/facility modifications.
- Works on problems of limited scope.
- Follows standard practices and procedures in analyzing situations or data from which answers can be readily obtained.
- Basic level use and general knowledge of industry practices, techniques, and standards.
- General application of engineering concepts and principles.
- Work is closely supervised for soundness of judgment and overall adequacy and accuracy.
- Contributions are usually limited to task-related activities.
Internal contacts include immediate manager, and other personnel in the group.
In addition to working closely with members of the Engineering Group, this individual will have regular contact with Manufacturing, Facility, Validation, and Quality clients.
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).