Manufacturing Operator 2 - Off-shift
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. Candidates will need to be flexible on shift. The possible shifts for this role are:
Tuesday - Friday
2:00 pm - 12:30 am (4 10 hr shifts)
Tuesday night - Saturday am
10:00 pm - 8:30 am (4 10 hr shifts)
Saturday, Sunday, Monday
7:00 am - 7:30 pm (3 12 hr shifts)
Saturday night, Sunday night, Monday night into Tuesday morning
7:00 pm - 7:30 am (3 12 hr shifts)
• 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.
• 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.
• 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.
Bachelors Degree and experience in an Aseptic Environment for more than one year.
We are a science-led global healthcare company with a special purpose: to help people do more, feel better, live longer. Our Vaccines business has a broad portfolio and innovative pipeline of vaccines to protect people of all ages. On average, each batch of vaccine will have undergone more than 100 quality checks before it is sent out, to ensure the vaccines meet world-class standards. We deliver over two million vaccine doses per day to people living in over 160 countries and are committed to continuously investing in our manufacturing facilities, improving our processes and building partnerships to ensure we meet the global growing needs for high quality vaccines.
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