Offers “General Electric”

Expires soon General Electric

Biomanufacturing Specialist

  • Uşak, Türkiye
  • Design / Civil engineering / Industrial engineering

Job description

3075825
Additional Cities

Marlborough
Career Level

Experienced
Relocation Assistance

Yes
Business

GE Healthcare
Business Segment

Healthcare Life Sciences
Function

Manufacturing
Country/Territory

United States
Additional States/Provinces

Massachusetts
Postal Code

01752-7217
Role Summary/Purpose

The Biomanufacturing Specialist is responsible for current Good Manufacturing Practices (cGMP) production activities, mainly in a clean room environment. In this role you will provide the technical and practical skills necessary to integrate new products into manufacturing within defined parameters of cost, product standards and available resources. Use state of the art equipment to identify, evaluate and develop procedures to make manufacturing reliable and efficient for customers.
Essential Responsibilities

1. Lead cGMP Biomanufacturing production activities, which include, but are not limited to, the following:
- On the floor Manufacturing support during project processing including all aspects of Cell Culture and Protein Purification.
-Providing technical supervision during Manufacturing operations according to standard operating procedures and batch instructions
-Writing, reviewing and revising of cGMP process documentation
-Supporting Quality documentation as necessary for project closeout
-Properly documenting cGMP Biomanufacturing activities
2. Operate Cell Culture and/or Protein Purification production equipment in a clean room environment, equipment to include: incubators, GE Wave Reactors, Single Use Bioreactors (XDR), GE AKTA Chromatography skids, Depth Filtration, Viral Filtration and Tangential Flow Filtration
3. Perform aseptic techniques within a clean room environment
4. Operate and troubleshoot cGMP Biomanufacturing equipment, including: pH/conductivity meters, single use mixing tanks (XDM’s), tubing fusers/sealers, filter integrity testers, cell counters, metabolite analyzers, peristaltic pumps, balances and biosafety cabinets (BSC)
5. Participate in technology transfer of processes from Process Development to Manufacturing.
6. Initiate and support process improvement projects, work across multiple teams to improve quality and process efficiency within Manufacturing
7. Lead deviation investigations and change control/protocol execution within established timelines
8. Create and revise Standard Operating Procedures (SOPs), Master Production Records (MPRs), required technical documents, protocols and reports
9. Perform real time daily review of executed cGMP documentation for accuracy (MPRs and supporting production data)
10. Mentors team members on Biomanufacturing activities and holds them accountable to quality, timely, completion
11. Perform other duties as assigned

Quality Specific Goals:
1. Aware of and comply 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
2. Complete all planned Quality & Compliance training within the defined deadlines
3. Identify and report any quality or compliance concerns and take immediate corrective action as required
4. Knowledge and understanding of requirements for software & hardware verifications and validations, electronic signature, document control, configuration change control, good documentation practices, calibration & Preventative Maintenance as applicable to assigned tasks
Qualifications/Requirements

1. Associate’s degree/equivalent plus a minimum of 3 years experience working in a cGMP manufacturing environment or High School diploma/equivalent plus a minimum of 4 years experience working in a cGMP manufacturing environment
2. Basic computer/data entry skills
3. Strong mathematical aptitude including Algebra and Geometry
4. Must understand oral/written technical local language
5. Demonstrated ability to communicate, receive and understand instructions regarding duties to be performed
Desired Characteristics

• M.S./M.A. in Biotechnology, or related field, with minimum 2 year’s experience in biologics manufacturing under cGMP
• B.S./B.A. in Biotechnology, or related field, with minimum of 4 year’s experience in biologics manufacturing under cGMP
• Associates Degree/ Biotechnology Certificate/Diploma with a minimum of 6 year’s experience in biologics manufacturing under cGMP
• Demonstrated ability to work in a rapidly changing climate and reacts well to change
• Strong attention to detail and have quality-minded work habits
• Reliable, dependable, and organized; ability to work additional hours as needed to support production
• Motivated, organized, flexible, creative and works well within a fast-paced, dynamic and team-oriented environment
• Experience with Single Use Mixers (XDMs), Single Use Reactors (XDRs), Wonderware software and Unicorn V7 software used for AKTA purification skid operation
• Cell Culture experience
• Protein Purification experience
• Experience with Trackwise, Electronic Document Management Systems or other electronic tracking software
About Us

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.
Learn More About GE Healthcare – Life
Sciences


Learn More About Careers at GE Healthcare – Life
Sciences


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, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or 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.
Primary Country

United States

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