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.
