Process Engineer II Job in Lexington 02421, Massachusetts US
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 frequently contact 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 problems of moderate scope and complexity and may refer to policies and practices for guidance.
Must be able to work in a fast-paced multi-disciplinary environment.
Responsibilities:
70% Operational support
• 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
• Determines corrective maintenance actions
• Follows up and corrects any safety related design/equipment issues
• Provides solutions to complex reliability and operational problems
• Provides guidance to maintenance personnel and actively participates in the decision making process on design improvement
• Understands how manufacturing SOPs interact with equipment/automation design and operation. Limited to SOPs impacted by changes, no knowledge of all mfg SOPs expected
• Provide technical input to manufacturing on SOP changes, Deviations, GMP Investigations and CAPAs
• Execute WOs assigned by customer groups, as well as ones initiated by Engr, when they apply to daily plant support or troubleshooting
• Ensure all site record docs are accurate and up to date (PIDs, etc)
• Provides guidance to maintenance personnel and actively participates in the decision making process on equipment performance and design improvements
• On call support 24/7
15% Small Project Support
• Accountable for all phases of the Change Control process for owned changes
• Owns and ensures timely closure of equipment related CAPA's
• 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.
• Re-engineer current disposable components as needed
10% Large Project Support
• Assists in determining Schedule requirements
• Provide peer review of changes
• Support engineering tests, FATs, SATs and equipment commissioning
• Assists in troubleshooting and remediation of exceptions found during validation
• Assist in releasing system for operation
5% Standards and Templates
• Review and approve basic engineering standard practices as required
• Limited focus, this will be secondary to operational support
Education and Experience Requirements:
Required education: Bachelors degree in Chemical or Mechanical Engineering
Minimum 2 years experience in a cGMP Engineering environment
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:
• Work with cross-functional groups in developing requirements and recommendations for highly complex system/facility modifications.
• Works on problems of moderate scope where analysis of situations or data requires a review of a variety of factors.
• Exercises judgment within defined procedures and practices to determine appropriate action.
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.
• Builds productive working relationships internally and externally.
Other Job Requirements:
• Ability to work at all Shire MA locations (Cambridge and Lexington)
• Expected to carry Smartphone 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%
Shire's Brave culture offers employees with diverse backgrounds the opportunity to enable those with life altering conditions to lead better lives
Shire is an Equal Opportunity and Affirmative Action Employer
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