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.