Biomanufacturing Associate 2 - Night Shift

Job description

3182689
Additional Cities

Marlborough
Career Level

Experienced
Relocation Assistance

No
Business

GE Healthcare
Business Segment

Healthcare Global Supply Chain
Function

Manufacturing
Country/Territory

United States
Additional States/Provinces

Massachusetts
Postal Code

01752-7217
Role Summary/Purpose

The Biomanufacturing Cleanroom Operator is responsible for current Good Manufacturing Practices (cGMP) production activities. Performing Manufacturing operations according to standard operating procedures and batch instructions. Responsibilities include training on cGMP manufacturing operations, which include but are not limited to the operation and monitoring of cell culture and/or purification equipment, media and solution preparation & writing, reviewing and revising of cGMP documentation.
Essential Responsibilities

Key Responsibilities/Essential Functions Include:
• Reads and follows work procedures and schematics or receives verbal instructions regarding duties to be performed
• Assist in the set up and preparation of equipment and production runs.
• Performs manufacturing operations and various tasks following procedures (SOPs), bills of materials, work instructions (Batch Records), and process aid sheets.
• Maintains daily production output.
• Works with team lead, engineers, supervisors, and managers to improve quality and process efficiency
• Perform required tests on equipment and record results.
• Participates in Quality Control inspections and Quality Assurance audits.
• Handle and deliver products and hazardous materials in compliance with all regulations and Company Policies.
• Complies with all EHS and Quality policies and procedures
• Maintain cleanliness of cleanroom in accordance with cGMPs and facility procedures.
• Complete regulatory paperwork for deliveries and for outgoing customer products
• Actively participate in maintaining a safe work environment by completing required training, providing suggestions for improving the health and safety program and bringing unsafe acts and/or conditions to the attention of management.
• Performs other duties as assigned.
Qualifications/Requirements

Qualifications/Requirements :
• Associates Degree/ Biotechnology Certificate/Diploma with a minimum of two years of experience in biologics manufacturing under cGMP.
• High School Diploma or equivalent with a minimum of 3 years of experience in biologics manufacturing under cGMP.
• Must be available to work Monday through Friday, 8:00 pm to 4:30 am.
• Demonstrates ability to work in a rapidly changing climate and reacts well to change.
• Demonstrates ability to communicate, receive and understand instructions regarding duties to be performed
• Demonstrates strong attention to detail and have quality-minded work habits
• Demonstrates ability to communicate with co-workers and leadership
• Demonstrates ability to follow instruction and standard operating procedures.
• Reliable, dependable, and organized.
• Able to recognize problems developing, not just occurring.
• Ability to work additional hours as needed to support production.
Desired Characteristics

Desired Characteristics :
• Associates degree in a scientific discipline or equivalent experience
• Prior experience working in a cGMP biopharmaceutical manufacturing environment
• Strong Buffer and Media preparation experience
• Cell Culture knowledge
• Protein Purification knowledge
• Experience with single-use biomanufacturing systems
About Us

GE Healthcare Life Sciences is a division of GE Healthcare, a part of the General Electric Company (NYSE:GE). The Life Sciences division of GE Healthcare is a $4 billion business, providing expertise and tools for a wide range of biotechnology and life sciences applications, including basic research of cells and proteins, drug discovery research, as well as tools to support large-scale manufacturing of biopharmaceuticals. It also supplies leading contrast agents, PET & nuclear medicine pharmaceuticals for diagnostic imaging in disease such as cancer, heart disease and neurological disorders.

GE Healthcare Life Sciences provides expertise and tools for a wide range of applications, including basic research of cells and proteins, drug discovery research, as well as tools to support large-scale manufacturing of biopharmaceuticals.
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.
Primary Country

United States
Primary State/Province

Massachusetts
Primary City

Marlborough