Aseptic Manufacturing Technician II

4 days ago

Philadelphia, Pennsylvania, United States Proclinical Staffing Full time
Aseptic Manufacturing Technician II Job Description

We are seeking a highly skilled Aseptic Manufacturing Technician II to join our team at Proclinical Staffing. As a key member of our manufacturing team, you will play a vital role in supporting the production of autologous cell therapy products.

Key Responsibilities:

  • 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.

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).

Compensation:

  • USD per hour

If you are interested in this opportunity, please contact Jackie Cerchio at j.cerchio@proclinical.com.

Proclinical Staffing 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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