Buffer and Formulation Service Operator

Proclinical is currently recruiting for a Buffer and Formulation Service Operator position with an international biopharmaceutical company located in Marietta, PA. Successful candidate will be responsible for loading and unloading materials, labeling according to SOPs, assembling valves, connectors, and other equipment and tools using Aseptic technique.

Job responsibilities:

• Use proper aseptic techniques 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.
• 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.
• 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.
• 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.
• 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.

Skills and Requirements:

• 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.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please call Brendan Thalheimer at (+1) 215-531-5299 or upload your resume on our website - www.proclinical.com.

A full job description is available on request.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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