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Pharmaceutical Machine Operator

3 months ago

Tampa, United States TekWissen LLC Full time
Job DescriptionJob DescriptionOverview:

TekWissen Group is a workforce management provider throughout the USA and many other countries in the world. Our client is a leading biotechnology company that combines technological insight with world-class manufacturing, scientific expertise, and process excellence and helps their customers deliver new and innovative medicines that help treat a wide range of diseases. Our client specializes in pharmaceutical ingredients, Bioscience, Biopharmaceuticals, Custom manufacturing, Biotechnology, Life science ingredients, Nutrition, Microbial Control, Agriculture, Materials Science, Personal Care, and cell and gene therapy.
Position: Machine Operator / Production WorkerLocation: Tampa, FL, 33634 Duration: 6 Months Job Type: Contract Work Type: OnsiteShift: Monday to Friday - 07:00 AM to 03:30 PMKey responsibilities:
  • Execute assembly instructions per Batch Record requirements for Packaging and Labeling processes in compliance with cGMP guidelines.
  • This will require on time and neat documentation during the execution to assure compliance.
  • Provide support to the Manufacturing Group, QA, Warehouse and Facility operations by complying with company and FDA cGMP requirements.
  • Responsible for the performance of cleaning of Primary and Secondary Packaging rooms and Packaging equipment.
  • This will include the corresponding Room Sanitizations per Departments procedures.
  • Follow batch record instructions in the execution of manual process for Primary and Secondary Packaging as applicable.
  • Assist in the operation and set-up of automated equipment in the performance of certain primary or secondary packaging operations.
  • Assist in the reconciliation and movement (Chain of custody) of materials between packaging areas and the warehouse.
  • Report any observations to QA, Team Lead, Equipment Specialist CPS Project Coordinator or Manager of potential issues that could result in deviation or investigation.
  • Perform Cleaning and Sanitization of Primary and Secondary Packaging rooms.
  • Support the Equipment Specialist in the execution of qualification protocols for new equipment as assigned.
  • Training on SOPs to remain current for job requirements, logbook entries and GMP documentation.
  • Attend applicable meetings, discussions, etc., in support of these projects to meet the Production Schedule.
  • Participate in safety processes and meetings as applicable.
  • Maintain a positive, professional and confidential relationship with sponsors. Comply with all state and federal regulatory requirements and guidelines.
  • Other applicable duties as assigned.
  • Adhere to all defined Safety and Sustainability requirements and expectations and seek clarification whenever Safety and Sustainability requirements and expectations are either unknown or unclear
  • Promptly report identified Safety and Sustainability issues, problems, deficiencies, errors, incidents, and/or opportunities to management and correct where possible
  • Stop work where deemed necessary to maintain safety
Key Requirements:
  • Experiecne in operating packaging machines
  • Experience and exposure in troubleshooting the equipment commonly used in the packaging process.
  • Pharma cGMP experience
  • Experiecne in pharmaceutical industry packaging line bottles, blistering process, manual packaging, good documentation practice experience, following SOP and following batch records.
TekWissen Group is an equal opportunity employer supporting workforce diversity.