Operate processing equipment in accordance with SOPs, in all classified areas (Grade A/B/C).
Complete 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 perform non-routine interventions without compromising aseptic environment.
Troubleshoot process equipment and interact with maintenance personnel.
Responsible for loading and unloading materials, labeling according to SOPs, assembling valves, connectors.
Recognize and report deviations or potential issues immediately to the management team.
Communicate and report status of equipment maintenance related issues to the area supervisor/manager and assist with actions necessary to resolve issues.
Perform all job responsibilities in compliance with applicable EHS/GMP regulations, guidelines, policies, GSK standard operating & safety procedures, and industry practice and Industrial Excellence initiatives.
Why you?
Basic Qualifications:
Bachelor's degree in a biological, chemical science, engineering or degree in other discipline if sufficient technical depth has been achieved from professional experience.
OR
High School Diploma with 2+ years manufacturing production, cGMP experience.
Preferred Qualifications:
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, clearly and accurately documenting all necessary batch documentation.