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Manufacturing Specialist II

In Massachusetts / United States

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Manufacturing Specialist II   

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JOB TITLE:

Manufacturing Specialist II

JOB TYPE:

JOB SKILLS:

JOB LOCATION:

Marlborough Massachusetts / United States

JOB DESCRIPTION:

Pay rate - $32.39/hr
Work hours: Wednesday to Saturday 7:00am to 5:30pm plus overtime as needed


What you’ll do:
• Responsible for current Good Manufacturing Practices (cGMP) production activities
• Read and perform Manufacturing operations according to Standard Operating Procedures (SOPs) and Master Production Records (MPRs)
• Routinely originate or revise Standard Operating Procedures, Master Production Records and Solution Preparation Records
• Operate and monitor cell culture and/or purification equipment
• Ability to work within ISO 5/7/8 clean room environments
• Review completed cGMP documentation for accuracy
• Operates cGMP Biomanufacturing equipment, including;
o pH/conductivity meters, single use mixing vessels (XDM’s), tubing fusers/sealers, filter integrity testers, cell counters, metabolite analyzers, peristaltic pumps, balances and biosafety cabinets (BSC)
• Performs media and solution preparation
• Performs aseptic techniques within a clean room environment
• Performs small and large scale cell culture production of mammalian cell lines, including cell counting, cell passaging and culture metabolite analysis
• Operates Cell Culture and/or Protein Purification production equipment in a cleanroom environment, including;
o Incubators, Wave Reactors, Single Use Bioreactors (XDR)
o Chromatography skids, Depth Filtration, Viral Filtration and Tangential Flow Filtration
• Knowledge and understanding of document control, calibration, verification, validation, acceptance activity, requirements to ensure compliance to validation, design and production requirements
• Works scheduled shift and other off-shift coverage as required
• Works with team leads; engineers, supervisors, and managers to improve quality and process efficiency
• 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

Qualifications:
• Associates Degree/ Biotechnology Certificate/Diploma with a minimum of 2 years experience in biologics manufacturing under cGMP.
• High School Diploma or equivalent with a minimum of 3 years experience in biologics manufacturing under cGMP.
• 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
• Demonstrates effective written and verbal communication skills

Preferred Qualifications
• 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 biomanufacturing systems

Position Details

POSTED:

Aug 02, 2021

EMPLOYMENT:

INDUSTRY:

SNAPRECRUIT ID:

S16204861215758355

LOCATION:

Massachusetts / United States

CITY:

Marlborough

Job Origin:

Jobsrus_organic_feed

A job sourcing event
In Dallas Fort Worth
Aug 19, 2017 9am-6pm
All job seekers welcome!

Manufacturing Specialist II    Apply

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Pay rate - $32.39/hr
Work hours: Wednesday to Saturday 7:00am to 5:30pm plus overtime as needed


What you’ll do:
• Responsible for current Good Manufacturing Practices (cGMP) production activities
• Read and perform Manufacturing operations according to Standard Operating Procedures (SOPs) and Master Production Records (MPRs)
• Routinely originate or revise Standard Operating Procedures, Master Production Records and Solution Preparation Records
• Operate and monitor cell culture and/or purification equipment
• Ability to work within ISO 5/7/8 clean room environments
• Review completed cGMP documentation for accuracy
• Operates cGMP Biomanufacturing equipment, including;
o pH/conductivity meters, single use mixing vessels (XDM’s), tubing fusers/sealers, filter integrity testers, cell counters, metabolite analyzers, peristaltic pumps, balances and biosafety cabinets (BSC)
• Performs media and solution preparation
• Performs aseptic techniques within a clean room environment
• Performs small and large scale cell culture production of mammalian cell lines, including cell counting, cell passaging and culture metabolite analysis
• Operates Cell Culture and/or Protein Purification production equipment in a cleanroom environment, including;
o Incubators, Wave Reactors, Single Use Bioreactors (XDR)
o Chromatography skids, Depth Filtration, Viral Filtration and Tangential Flow Filtration
• Knowledge and understanding of document control, calibration, verification, validation, acceptance activity, requirements to ensure compliance to validation, design and production requirements
• Works scheduled shift and other off-shift coverage as required
• Works with team leads; engineers, supervisors, and managers to improve quality and process efficiency
• 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

Qualifications:
• Associates Degree/ Biotechnology Certificate/Diploma with a minimum of 2 years experience in biologics manufacturing under cGMP.
• High School Diploma or equivalent with a minimum of 3 years experience in biologics manufacturing under cGMP.
• 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
• Demonstrates effective written and verbal communication skills

Preferred Qualifications
• 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 biomanufacturing systems


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