Site Name: USA - Pennsylvania - Marietta
Posted Date: Sep 30 2020
*Please note that the Operator 2 Work Hours are M-F from 3:00pm-11:30pm.

As an Operator 2, you 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.

This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:

• 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 change out), 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 / GMP regulations, guidelines, policies, GSK standard operating & safety procedures, and industry practice and Industrial Excellence initiatives.

• Bachelors Degree in a biological, chemical science, engineering Or related Degree.
  
• Previous manufacturing or laboratory experience requiring aseptic or sterile technique required.
• Experience with operate pumps, scales and PH meters.
• Experience in working around acids, bases, oxidizers and cleaning solvents while wearing appropriate PPE.
• Experience with performing calculations using simple mathematical formulas using fractions, percentages and significant numbers. The ability to measure volume and weight.
• Experience with following detailed processing instructions, 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.
• 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.)

• Operating at pace and agile decision-making - using evidence and applying judgement to balance pace, rigor and risk.
• Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
• Continuously looking for opportunities to learn, build skills and share learning.
• Sustaining energy and well-being
• Building strong relationships and collaboration, honest and open conversations.
• Budgeting and cost-consciousness