Sign in

Cleanroom Operator - Biomanufacturing

Company:
software galaxy system
Location:
Marlborough, Massachusetts, United States
Salary:
$20 - $24/Hr
Posted:
December 07, 2016
Description:

Job Description:

JOB TITLE/TYPE: CLEANROOM OPERATOR - BIOMANUFACTURING

Function: Manufacturing Family: Bridge Manufacturing Services Band: Other Salary

Description:

• The Biomanufacturing Cleanroom Operator is responsible for performing Manufacturing operations according to standard operating procedures and batch instructions.

• Responsibilities include training on cGMP manufacturing operations, operation and monitoring of cell culture and/or purification equipment, writing and reviewing cGMP documentation.

Key responsibilities / essential functions:

• Demonstrate effective written and verbal communication skills.

• Reads and follows standard operating procedures and master production records or receives verbal instructions regarding duties to be performed.

• Review completed cGMP documentation for accuracy.

• Routinely originate and revise standard operating procedures, master production records and solution preparation records.

• Assist in the set up and preparation of equipment and production runs.

• Operates Cell Culture and/or Purification production equipment in a cleanroom environment.

• Operates general manufacturing equipment to formulate buffers and Media.

• Works with team lead, engineers, supervisors, and managers to improve quality and process efficiency.

• Handle and deliver products and hazardous materials in compliance with all regulations and Company Policies.

• 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.

• Complies with all EHS and Quality policies and procedures.

• Maintain cleanliness of cleanroom in accordance with cGMPs and facility procedures.

• Perform other duties as assigned.

Quality Specific Goals:

• 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.

• Complete all planned Quality & Compliance training within the defined deadlines.

• Identify and report any quality or compliance concerns and take immediate corrective action as required.

• Knowledge and understanding of document control, calibration, verification, validation, acceptance activity, requirements to ensure compliance to validation, design and production requirements.

Qualifications:

• Associate’s degree in Science or High School Diploma and a minimum of two years of experience in biologics manufacturing under cGMP

• Ability to communicate, receive and understand instructions regarding duties to be performed

• Demonstrated ability to detail and have quality-minded work habits

• Demonstrated ability to communicate with co-workers and leadership

• Demonstrated ability to follow instruction and standard operating procedures.

• Ability to work additional hours as needed to support production.

Preferred Qualifications

• Associates degree in a scientific discipline or equivalent experience

• Cell Culture experience

• Protein Purification experience

• Prior experience working in a cGMP biopharmaceutical manufacturing environment

• Experience with single-use systems is preferred