BS/BA or Associates Degree in biological sciences, chemical sciences, engineering or equivalent technical discipline. Degree in other discipline (or lack of degree) may be considered if sufficient technical depth has been achieved from professional experience.
• 2+ years directly related manufacturing experience in the pharmaceutical or biotechnology industry, with the demonstration of a high level of performance
• Understanding of the basic FDA cGMP regulations
• Strong verbal and written skills.
• Must be able to follow detailed processing instructions as well as accurately documenting all necessary documentation.
• Ability to work a shift that covers a 24/7 operation
• Ability to lift and carry materials weighing as much as 50lbs.
• Strong documentation practices
• Demonstrated ability to work effectively in a team
Under the direction of senior personnel, performs production operations including fermentation or cell culture operations, preparation of media and buffer solutions, chromatographic separation, filtration and concentration operation, etc as well as being involved in both start-up and product changeover activities. Will be responsible for completing daily biopharm manufacturing tasks as well as supporting more in-depth, long term projects.
• Operation of bioprocess equipment under strict adherence to and enforce cGMP, OSHA and polices and regulations, or others as required.
• Completing daily manufacturing tasks per standard operating procedures and batch document instructions.
• Monitors critical process parameters
• Documenting all manufacturing activities clearly and acruately.
• Assist in the training of less experienced team members in relevant process, cGMP and safety procedures.
• Actively participates in effective troubleshooting of equipment and processing problems.
• Ensures all processing equipment and materials necessary are adequate and available to set the team up for success.
• Maintains a high level of mechanical and technical aptitude and training.
• During technical transfer and the start up activities, provide input on design and operation of equipment.
• Ensures all production activities are completed in a safe and compliant manor.
• Actively participates in the creation and revision of Batch Records, Work Instructions, Standard Operating Procedures and other GMP documents.Identify, develop and implement process improvements Will work with some hazardous materials under the appropriate safety procedures
• Receive, stage and track materials
• Identify process deviations and collaboratively participate in the investigations and corrective/preventive actions, as well as closure of maintenance work orders.
• Assists with problems of moderate scope where analysis of situation or data requires a review of identifiable factors.Monitor and audit work processes to ensure compliance and completion of targets
• Maintain cGMP training proficiency to ensure compliance
You may apply for this position online by selecting the Apply now button.
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