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Manufacturing Technician

In California / United States

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Manufacturing Technician   

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JOB TITLE:

Manufacturing Technician

JOB TYPE:

JOB SKILLS:

JOB LOCATION:

Oceanside California / United States

JOB DESCRIPTION:


Manufacturing Technician III
Department
Downstream Manufacturing, Oceanside
Job Responsibilities
• The Manufacturing Technician III will largely be responsible for technical writing for the Manufacturing department, in addition to performing operations.
• Experience drafting Quality System documents (i.e., deviations, change managements, batch records, standard operating procedures, etc.) is required.
• The Manufacturing Technician III is also responsible for the operation of large and small scale chromatography columns and skids, viral filtration, ultrafiltration/diafiltration skids, bioreactors, and centrifuges, as well as all related equipment and systems necessary to clean, configure, sanitize/sterilize and maintain said equipment.
• Operation and practical knowledge of glass washers, autoclaves, filters, pumps and analytical equipment to support and monitor the process is expected.
• Safety and Compliance are the two primary objectives of manufacturing operations.
• Reports to Team Lead on a regular basis on line performance and reports any issues that need to be resolved.
• Expected duties also include planning and executing the safe and efficient operation of assigned processes, Good Documentation Practices, timely communication of deviations, incidents and/or safety concerns and all relevant housekeeping duties to ensure the work areas are kept to a high level of cleanliness and inspection readiness.
• Involvement in planning and full execution/proper documentation of all operations associated with:
o Buffer and media preparation
o Upstream Production
o Protein Purification Production
o Clean in Place (CIP) and Steam in Place (SIP) of fixed tanks/vessels and portable equipment and Clean out of Place (COP)/Glasswash of misc. parts and equipment
o Proficiency and routine maintenance of analytical equipment including but not limited to: pH/conductivity meters, bioanalyzers, osmometers, benchtop centrifuges, cell counters and microscopes
• This position will be utilized by both Upstream and Downstream Manufacturing teams.
• Experience with DeltaV Automation Systems and Unicorn System Control or equivalent
• Aseptic Processing experience and knowledge required.
• Knowledge of quality systems, validation principles, regulatory and ICH guidelines and multi-product controls required.
• Background or understanding of Lean concepts (Kaizen, 5S, KanBan) desired.
• Works under demanding production schedules and strict compliance/quality requirements.
• Coordination with support groups including, but not limited to: Process Development, Quality Assurance and Control, Calibration, Maintenance, Validation, and Materials Management as a Manufacturing representative.
• Ability to work independently and in teams, proactive and self-managing, proven problem solving as well as a detailed and organized approach are key components to the success of this candidate.
• Must be flexible to work day, swing, or night shifts, and/or weekends.

Knowledge, Experience, and Skills:
? 0 – 4 years of relevant experience with a Bachelors degree in engineering or scientific discipline
? Prior experience in a Biologics cGMP related industry is required.
? Knowledge of written Standard Operating Procedures (SOPs) and Master Batch Records
? Good verbal, written, and interpersonal communication skills are required
? Experience with Quality systems
? Working knowledge in Microsoft Office applications and administrative policies
? Ability to follow direction and work under minimal supervision
? Demonstrates capability in organizing more complex activities in a manufacturing processob Title
Manufacturing Technician III
Department
Downstream Manufacturing, Oceanside
Job Responsibilities
• The Manufacturing Technician III will largely be responsible for technical writing for the Manufacturing department, in addition to performing operations.
• Experience drafting Quality System documents (i.e., deviations, change managements, batch records, standard operating procedures, etc.) is required.
• The Manufacturing Technician III is also responsible for the operation of large and small scale chromatography columns and skids, viral filtration, ultrafiltration/diafiltration skids, bioreactors, and centrifuges, as well as all related equipment and systems necessary to clean, configure, sanitize/sterilize and maintain said equipment.
• Operation and practical knowledge of glass washers, autoclaves, filters, pumps and analytical equipment to support and monitor the process is expected.
• Safety and Compliance are the two primary objectives of manufacturing operations.
• Reports to Team Lead on a regular basis on line performance and reports any issues that need to be resolved.
• Expected duties also include planning and executing the safe and efficient operation of assigned processes, Good Documentation Practices, timely communication of deviations, incidents and/or safety concerns and all relevant housekeeping duties to ensure the work areas are kept to a high level of cleanliness and inspection readiness.
• Involvement in planning and full execution/proper documentation of all operations associated with:
o Buffer and media preparation
o Upstream Production
o Protein Purification Production
o Clean in Place (CIP) and Steam in Place (SIP) of fixed tanks/vessels and portable equipment and Clean out of Place (COP)/Glasswash of misc. parts and equipment
o Proficiency and routine maintenance of analytical equipment including but not limited to: pH/conductivity meters, bioanalyzers, osmometers, benchtop centrifuges, cell counters and microscopes
• This position will be utilized by both Upstream and Downstream Manufacturing teams.
• Experience with DeltaV Automation Systems and Unicorn System Control or equivalent
• Aseptic Processing experience and knowledge required.
• Knowledge of quality systems, validation principles, regulatory and ICH guidelines and multi-product controls required.
• Background or understanding of Lean concepts (Kaizen, 5S, KanBan) desired.
• Works under demanding production schedules and strict compliance/quality requirements.
• Coordination with support groups including, but not limited to: Process Development, Quality Assurance and Control, Calibration, Maintenance, Validation, and Materials Management as a Manufacturing representative.
• Ability to work independently and in teams, proactive and self-managing, proven problem solving as well as a detailed and organized approach are key components to the success of this candidate.
• Must be flexible to work day, swing, or night shifts, and/or weekends.

Knowledge, Experience, and Skills:
? 0 – 4 years of relevant experience with a Bachelors degree in engineering or scientific discipline
? Prior experience in a Biologics cGMP related industry is required.
? Knowledge of written Standard Operating Procedures (SOPs) and Master Batch Records
? Good verbal, written, and interpersonal communication skills are required
? Experience with Quality systems
? Working knowledge in Microsoft Office applications and administrative policies
? Ability to follow direction and work under minimal supervision
? Demonstrates capability in organizing more complex activities in a manufacturing process





Position Details

POSTED:

Aug 02, 2021

EMPLOYMENT:

INDUSTRY:

SNAPRECRUIT ID:

S162048614867410116

LOCATION:

California / United States

CITY:

Oceanside

Job Origin:

Jobsrus_organic_feed

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

Manufacturing Technician    Apply

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Manufacturing Technician III
Department
Downstream Manufacturing, Oceanside
Job Responsibilities
• The Manufacturing Technician III will largely be responsible for technical writing for the Manufacturing department, in addition to performing operations.
• Experience drafting Quality System documents (i.e., deviations, change managements, batch records, standard operating procedures, etc.) is required.
• The Manufacturing Technician III is also responsible for the operation of large and small scale chromatography columns and skids, viral filtration, ultrafiltration/diafiltration skids, bioreactors, and centrifuges, as well as all related equipment and systems necessary to clean, configure, sanitize/sterilize and maintain said equipment.
• Operation and practical knowledge of glass washers, autoclaves, filters, pumps and analytical equipment to support and monitor the process is expected.
• Safety and Compliance are the two primary objectives of manufacturing operations.
• Reports to Team Lead on a regular basis on line performance and reports any issues that need to be resolved.
• Expected duties also include planning and executing the safe and efficient operation of assigned processes, Good Documentation Practices, timely communication of deviations, incidents and/or safety concerns and all relevant housekeeping duties to ensure the work areas are kept to a high level of cleanliness and inspection readiness.
• Involvement in planning and full execution/proper documentation of all operations associated with:
o Buffer and media preparation
o Upstream Production
o Protein Purification Production
o Clean in Place (CIP) and Steam in Place (SIP) of fixed tanks/vessels and portable equipment and Clean out of Place (COP)/Glasswash of misc. parts and equipment
o Proficiency and routine maintenance of analytical equipment including but not limited to: pH/conductivity meters, bioanalyzers, osmometers, benchtop centrifuges, cell counters and microscopes
• This position will be utilized by both Upstream and Downstream Manufacturing teams.
• Experience with DeltaV Automation Systems and Unicorn System Control or equivalent
• Aseptic Processing experience and knowledge required.
• Knowledge of quality systems, validation principles, regulatory and ICH guidelines and multi-product controls required.
• Background or understanding of Lean concepts (Kaizen, 5S, KanBan) desired.
• Works under demanding production schedules and strict compliance/quality requirements.
• Coordination with support groups including, but not limited to: Process Development, Quality Assurance and Control, Calibration, Maintenance, Validation, and Materials Management as a Manufacturing representative.
• Ability to work independently and in teams, proactive and self-managing, proven problem solving as well as a detailed and organized approach are key components to the success of this candidate.
• Must be flexible to work day, swing, or night shifts, and/or weekends.

Knowledge, Experience, and Skills:
? 0 – 4 years of relevant experience with a Bachelors degree in engineering or scientific discipline
? Prior experience in a Biologics cGMP related industry is required.
? Knowledge of written Standard Operating Procedures (SOPs) and Master Batch Records
? Good verbal, written, and interpersonal communication skills are required
? Experience with Quality systems
? Working knowledge in Microsoft Office applications and administrative policies
? Ability to follow direction and work under minimal supervision
? Demonstrates capability in organizing more complex activities in a manufacturing processob Title
Manufacturing Technician III
Department
Downstream Manufacturing, Oceanside
Job Responsibilities
• The Manufacturing Technician III will largely be responsible for technical writing for the Manufacturing department, in addition to performing operations.
• Experience drafting Quality System documents (i.e., deviations, change managements, batch records, standard operating procedures, etc.) is required.
• The Manufacturing Technician III is also responsible for the operation of large and small scale chromatography columns and skids, viral filtration, ultrafiltration/diafiltration skids, bioreactors, and centrifuges, as well as all related equipment and systems necessary to clean, configure, sanitize/sterilize and maintain said equipment.
• Operation and practical knowledge of glass washers, autoclaves, filters, pumps and analytical equipment to support and monitor the process is expected.
• Safety and Compliance are the two primary objectives of manufacturing operations.
• Reports to Team Lead on a regular basis on line performance and reports any issues that need to be resolved.
• Expected duties also include planning and executing the safe and efficient operation of assigned processes, Good Documentation Practices, timely communication of deviations, incidents and/or safety concerns and all relevant housekeeping duties to ensure the work areas are kept to a high level of cleanliness and inspection readiness.
• Involvement in planning and full execution/proper documentation of all operations associated with:
o Buffer and media preparation
o Upstream Production
o Protein Purification Production
o Clean in Place (CIP) and Steam in Place (SIP) of fixed tanks/vessels and portable equipment and Clean out of Place (COP)/Glasswash of misc. parts and equipment
o Proficiency and routine maintenance of analytical equipment including but not limited to: pH/conductivity meters, bioanalyzers, osmometers, benchtop centrifuges, cell counters and microscopes
• This position will be utilized by both Upstream and Downstream Manufacturing teams.
• Experience with DeltaV Automation Systems and Unicorn System Control or equivalent
• Aseptic Processing experience and knowledge required.
• Knowledge of quality systems, validation principles, regulatory and ICH guidelines and multi-product controls required.
• Background or understanding of Lean concepts (Kaizen, 5S, KanBan) desired.
• Works under demanding production schedules and strict compliance/quality requirements.
• Coordination with support groups including, but not limited to: Process Development, Quality Assurance and Control, Calibration, Maintenance, Validation, and Materials Management as a Manufacturing representative.
• Ability to work independently and in teams, proactive and self-managing, proven problem solving as well as a detailed and organized approach are key components to the success of this candidate.
• Must be flexible to work day, swing, or night shifts, and/or weekends.

Knowledge, Experience, and Skills:
? 0 – 4 years of relevant experience with a Bachelors degree in engineering or scientific discipline
? Prior experience in a Biologics cGMP related industry is required.
? Knowledge of written Standard Operating Procedures (SOPs) and Master Batch Records
? Good verbal, written, and interpersonal communication skills are required
? Experience with Quality systems
? Working knowledge in Microsoft Office applications and administrative policies
? Ability to follow direction and work under minimal supervision
? Demonstrates capability in organizing more complex activities in a manufacturing process






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