Operator 2

Basic qualifications:

  • Bachelors degree OR High School Diploma with sufficient technical depth achieved from professional experience in an Aseptic environment
  • Previous manufacturing or laboratory experience requiring aseptic or sterile technique required.

Preferred qualifications:

Bachelors Degree and experience in an Aseptic Environment for more than one year.

Details:

Why GSK? Because GSK's vaccines business puts the customer at the heart of everything we do. That's why we define our vaccines mission as: Protecting • Human • Kind. Protecting because we strive to turn the science of immunology into high-quality, practical protection against disease; Human because we are investing time in understanding and delivering on our customers' needs and helping them achieve their vaccination goals; and Kind because we recognize and act on our responsibilities to serve societies, rich and poor.

The operator will 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.

Key Responsibilities:

  • 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.
  • 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.

Qualifications:

  • 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.

Contact information:

You may apply for this position online by selecting the Apply now button.

If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK HR Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).GSK is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.

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