Service Operator - Buffer/Formulation Level 1 US Job Summary
- 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.
Education & Qualifications
- 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,standard operating & safety procedures, and industry practice and Industrial Excellence initiatives.
- 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.
- Medical, Dental, and Vision Insurance
- 401K Plan with Company Match
- Life and AD&D Insurance
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.