Manufacturing Technician - III
Company: ACS Solutions
Location: Oceanside
Posted on: January 12, 2021
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Job Description:
Job Title : Manufacturing Technician - IIILocation : Oceanside,
CADuration : 5 monthsJob Description:* 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 online 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:* Buffer and media preparation* Upstream Production* Protein
Purification Production* Clean in Place (CIP) and Steam in Place
(SIP) of fixed tanks/vessels and portable equipment and Cleanout of
Place (COP)/Glasswash of misc. parts and equipment* 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.Job Requirements:* Knowledge,
Experience, and Skills: 0 - 4 years of relevant 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
Keywords: ACS Solutions, Oceanside , Manufacturing Technician - III, Professions , Oceanside, California
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