Lead System Designer

Job description

3271296
Additional Cities

Marlborough, boston, worcester, Providence, Hartford, Nashua
Career Level

Experienced
Relocation Assistance

No
Business

GE Healthcare
Business Segment

Healthcare Life Sciences
Function

Engineering/Technology
Country/Territory

United States
Additional States/Provinces

Connecticut, Massachusetts, New Hampshire, Rhode Island
Postal Code

01752
Role Summary/Purpose

The Enterprise Solutions organization is seeking a Lead System Designer (LSD) to lead system design for FlexFactory single-use manufacturing systems. As LSD, work with a cross-functional team and be accountable for system design of the FlexFactory, automated equipment assembly, and ensure compliance with applicable regulatory requirements while optimizing performance for the customer’s process, operation, facility layout and regional location.
Essential Responsibilities

The Enterprise Solutions organization is an initiative within GE Life Sciences that focus on establishing bio-pharmaceutical manufacturing capacity for customers. By leveraging on the business units extensive product portfolio and process know-how the aim is to sell projects to customers who wants to set up their own manufacturing plant.
The Lead System designer will be responsible for the FlexFactory system design which includes but not limited to the generation of relevant design documents including Process Flow Diagrams (PFDs), equipment lists, utility requirements, process descriptions, user requirements specification (URS), general specification (GS), equipment configurations and design approval packages for the FlexFactory components. In this role, be responsible for providing feasible, reliable and profitable macro level design based on customer needs and regulatory requirements. You will have overall design responsibility for the FlexFactory equipment, consumable and accessory selection and specification, utility requirements, automation requirements, design documentation generation, testing protocol review and approval.
You will have the opportunity to lead the design control process from requirements development and design planning to final design approval by customer, while ensuring applicable customer requirements / specification (URS) can be met by the FlexFactory design, and ultimately fulfilled by the end product. You will also initiate the FlexFactory equipment product code registration.
Support Manufacturing Group to ensure the completeness of the TOP, equipment set-up for Functional Testing & FAT. Support Customers questions/issues during Factory Acceptance Test (FAT) and manage FAT deviation punch list.
Coordinate the detailed design and solve any design issues during the design phase and acts as a contract for system design related questions.
Participate in developing and updating the FlexFactory project schedule.

Support customer meetings by providing system hardware understanding. Develop, explore and recommend manufacturing concepts to fit customer needs/facility requirements.
• Assure compliance with the GEHC Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulations as they apply to this job type/position
• Work closely with Customer’s Subject Matter Experts (SMEs) to ensure continuous exchange of critical and technical information needed to execute design activities on time
• Complete all planned Quality & Compliance training within defined deadlines
• Identify and report any quality or compliance concerns and take immediate corrective action as required
• Work closely with Process Design Engineers to ensure that the equipment specification meets customer and process needs, and that equipment layout is optimized for the customer facility
• Ensure compliance/closure of Regulatory and Quality requirements before approving Design Control FDRs and NPI program milestones
• Lead continuous improvement activities by driving the implementation of process and product quality improvement initiatives
• Approximately 10-30% travel depending on project specifics and geographic location
Qualifications/Requirements

• BS or MS degree in biochemical / chemical engineering or a related engineering/life Science discipline
• Minimum of 5 years of relevant bioprocess experience
• Working knowledge of pharmaceutical/biotech processes, equipment hardware, and single use technology
• Thorough knowledge of biologics CMC, cGMP manufacturing requirements
• Technical understanding of automation systems used in the biopharma (Delta V, PLC, PI, etc.)
• Experience in working/leading within cross functional teams
• Experience with AutoCAD, Visio, MS Project, SuperPro
Desired Characteristics

• Master’s Degree
• Disposable technology design and application experience
• 2 years of direct experience working in a pilot plant or GMP manufacturing facility
• Detail oriented, excellent at critical analysis and problem solving
• Experience working in global business environment with sound understanding of global processes
• Open to a changing environment
• Structured, organized, analytical, team oriented
About Us

GE Healthcare Life Sciences www.corporate.gehealthcare.com There is no other life sciences company quite like GE Healthcare Life Sciences. A $5 billion business with more than 11,000 individuals in over 100 countries, we are at work enabling a new era in medicine. For more than 60 years, GE Healthcare Life Sciences has globally supported the development and use of new therapies, helping accelerate the journey from biological understanding to clinical therapy. GE Healthcare Life Sciences works with cutting edge technology enabling and advancing the discovery, diagnosis and medical treatments of the present and the future. We are accelerating biology to cell therapy in ways no other company can. Follow us on Facebook and Twitter and watch our discoveries in action on our YouTube channel.
GE offers a great work environment, professional development, challenging careers, and competitive compensation. GE is anEqual Opportunity Employer . Employment decisions are made without regard to race, color, religion, national or ethnic origin, gender (including pregnancy), sexual orientation, gender identity or expression, age, disability, veteran status or any other characteristics protected by law.
Additional Eligibility Qualifications

GE will only employ those who are legally authorized to work in the United States for this opening.
Primary Country

United States
Primary State/Province

Massachusetts
Primary City

Marlborough