Aseptic Manufacturing Technican II

Aseptic Manufacturing Technican II- Contract - Philadelphia, PA

Proclinical is seeking a dedicated Aseptic Manufacturing Technician II to play a vital role in a autologous cell therapy manufacturing program. This role requires a comprehensive understanding of theories, techniques, and principles to support manufacturing processes.

Primary Responsibilities:

The successful candidate will be involved in various tasks, including cleaning, sanitization, preparation, and product fulfillment for commercial and clinical use. A background in cell culture, aseptic gowning and qualification, and ISO class 5 cleanroom operations is highly desirable.

Skills & Requirements:

• Bachelor's degree or some post-secondary education.
• Demonstrated technical knowledge of aseptic processing in cleanroom environments.
• Ability to mentor and provide best practices to new techniques.
• Proficiency in English, especially for Good Documentation Practices, and Microsoft (Excel, Word, Outlook).
• Ability to perform arithmetic calculations accurately and reproducibly.
• Ability to build relationships quickly and credibly.
• Ability to work successfully in a fast-paced, team-oriented environment.
• Experience in biopharmaceutical-based GMP manufacturing operations, including experience in cell culture and associated downstream processing (preferred).
• Familiarity with 21 CFR Part 11 and standard GxP best practices and FDA (preferred).

The Aseptic Manufacturing Technican II's responsibilities will be:

• Develop a comprehensive understanding of GMP and cell therapy manufacturing processes.
• Complete training sessions and maintain training documentation.
• Comply with quality standards and requirements.
• Provide operational support functions, including materials stocking and transfer, kit preparation, reagent preparation, room readiness, cleaning activities, and equipment maintenance.
• Perform document review, including executed Batch Records and Logbooks.
• Support documentation needs, including review of SOPs, Batch Records, Deviations, CAPAs, etc.
• Support technical transfer and additional research-level testing activities.
• Perform basic revisions to reflect current procedures accurately.
• Support departmental projects in a contributor capacity.
• Attend daily huddle meetings and escalate issues/concerns to Area Management.
• Adhere to Good Manufacturing Practices (GMP) and Standard Operating Procedures (SOPs), including Good Documentation Practices (GDP).
• Comply with Safety SOPs, SDS sheets, and laboratory procedures per company policy and OSHA regulations.

Compensation:

• USD 28.00 - 31.75 per hour

If you are having difficulty in applying or if you have any questions, please contact Jackie Cerchio at j.cerchio@proclinical.com

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.