- 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 performs 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:
We are looking for professionals with these required skills to achieve our goals:
- 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.
- Basic computer skills required.