Bioprocess Engineer – System Design

Job description

3324799
Additional Cities

Marlborough, Worcester, Boston, Hartford, Nashua, Providence
Career Level

Experienced
Relocation Assistance

No
Business

GE Healthcare
Business Segment

Healthcare BioPharma
Function

Engineering/Technology
Country/Territory

United States
Additional States/Provinces

Connecticut, Massachusetts, New Hampshire, Rhode Island
Postal Code

01752
Role Summary/Purpose

We are seeking a System Designer who will support and be accountable for system design of our FlexFactory single-use manufacturing system and automated equipment assembly by ensuring compliance of regulatory requirements by optimizing performance for the customer’s process, operation, facility layout and regional location.
Essential Responsibilities

Enterprise Solutions focuses on establishing biopharmaceutical manufacturing capacity for customers by leveraging our extensive product portfolio and process know-how to outfit customers with their own manufacturing plant.
The 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. . The Lead System Designer will be responsible for providing feasible, reliable and profitable macro level design based on customer needs and regulatory requirements.  LSD has the 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. 
·  Lead the design control process from requirements development and
design planning to final design approval by customer. 

·  Ensure applicable customer requirements specification (URS) can be met by the
FlexFactory design, and ultimately fulfilled by the end product. 
·  Initiate the
FlexFactory equipment product code registration. 
·  Interface and coordinate with a
cross-functional team of engineers, Process Design Engineers and
customer. 
·  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
100 Results Way
Marlborough MA
01752
Modality Shift 1
understanding. 
·  Develop, explore and recommend manufacturing concepts to fit
customer needs/facility requirements. 
·  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.
·  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
·  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 3 years of relevant bioprocess experience
Working knowledge of pharmaceutical/biotech processes, equipment hardware, and single use
technology
Knowledge of biologics CMC, cGMP manufacturing requirements
Technical understanding of automation systems used in the biopharma (Delta V, PLC, PI, etc.)
Experience in working within cross functional teams
Open to a changing environment
Structured, organized, Analytical, Team oriented
Experience with AutoCAD, Visio, MS Project, SuperPro
Fluent in English both verbally and in writing
Desired Characteristics

·  Master’s Degree

·  Disposable technology design and application experience

·  1 year 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
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.
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. Any offer of employment is conditioned upon the successful completion of a drug screen (as applicable).
Primary Country

United States
Primary State/Province

Massachusetts
Primary City

Marlborough