Operator

• 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 autoloading equipment using automated control systems, unloading of autoclaves, and management of sterilized components.
• Operate processing equipment by 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 autoloading equipment using automated control systems; perform automatic weight checks; assist with and performs non-routine interventions without compromising the 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 the 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 the 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.
• Perform all job responsibilities in compliance with applicable EHS and GMP regulations, guidelines, policies, GSK standard operating & safety procedures, and industry practice and Industrial Excellence initiatives.

Education and skills:

• BS or BA in biological, chemical science, engineering, or degree in another discipline if sufficient technical depth has been achieved from professional experience. Instead of a 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 is required 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.