ROLE = FFL Operator
Duration = One year from start date
FOR SHIFT 1 – 1st shift: M-F, 7:00AM – 3:30PM (5 days, 8 hours per shift)
100% onsite work
Use proper aseptic technique while performing tasks in the Grade A/B areas to include: bulk formulation, vial filling, routine and non-routine aseptic interventions; operating filling and auto loading equipment using automated control systems, unloading of autoclaves and management of sterilized components.
• Operate processing equipment in accordance with SOPs, in all classified areas (Grade A/B/C).
• Actively participate in troubleshooting processes and equipment problems as well as assisting the supervisor in completing all necessary paperwork associated with investigations, deviations and remarks.
• Use proper aseptic technique while performing tasks in the Grade A/B areas to include: filling line, routine aseptic interventions (pulling of samples, EM monitoring & clearing downed vials), non-routine aseptic interventions (filler setup, needle changeout), operating filling and auto loading equipment using automated control systems; perform automatic weight checks; assist with and performs non-routine interventions without compromising aseptic environment.
• Actively participate in the creation and revision of batch records, standard operating procedures, protocols, and all other GMP documents.
• Troubleshoot process equipment and interact with maintenance personnel
• Demonstrate proficiency as outlined in training requirements for equipment systems and position.
• Responsible for loading and unloading materials, labeling according to SOPs, assembling valves, connectors, and other equipment and tools using Aseptic technique.
• Recognize and report deviations or potential issues immediately to the management team.
• Perform all job responsibilities in compliance with applicable regulations, guidelines, policies, standard operating procedures, and industry practice and Industrial Excellence initiatives.
• Communicate and report status of equipment maintenance related issues to the area supervisor / manager, and assist with actions necessary to resolve issues.
• Work on any assignment as directed.
• BS or BA in a biological, chemical science, engineering or degree in other discipline if sufficient technical depth has been achieved from professional experience.
• In lieu of degree, candidates with sufficient technical depth achieved from professional experience in an Aseptic environment may be considered.
• Previous manufacturing or laboratory experience requiring aseptic or sterile technique required.
• Some mechanical aptitude required in order to operate pumps, scales and PH meters.
• The capability to maintain attention to detail and quality and a high level of integrity and confidentiality, while completing multiple or repetitive tasks and meeting timelines and deadlines.
• Ability to read, understand, follow and comply with technical and written documents (SOPs.)
• Ability to work around acids, bases, oxidizers and cleaning solvents while wearing appropriate PPE.
• Ability to perform calculations using simple mathematical formulas using fractions, percentages and significant numbers. The ability to measure volume and weight.
• Must be able to follow detailed processing instructions as well as clearly and accurately documenting all necessary batch documentation.
• Basic computer skills required
• Ability to complete and maintain Aseptic gowning requirements. Must be able to work while wearing full protective gowning required for GMP areas for an entire shift.
• Physical requirements include stooping, standing, climbing and lifting of between 30 - 50 lbs.
• Ability to establish and maintain working relationships cross functionally including production, QA, QC, engineering, validation, and maintenance.
• The ability to communicate effectively, both verbally and in writing, to all levels within the organization.
• Position may require employees to work in a 24/7 rotational schedule. This schedule will include holidays, and weekends; over-time may be required. Work closely with shift team to achieve goals in a 24/7 cGMP Production Environment.
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