Aseptic Processing Technician

Description:

A biotech company in Philadelphia is seeking an Aseptic Processing Technician to join the team at their Spring Garden site. This facility produces a critical raw material used in the company’s TIL process. The critical raw material is processed from leukapheresis units and frozen. Processing is performed in an ISO 7 cleanroom within an ISO 5 biological safety cabinet.

Responsibilities:

Complete training sessions and ensure training documentation is maintained.

Proficiently carry out procedures to achieve a consistent, error-free execution of daily job assignments.

Work as part of a team to produce each lot- accurately and fully complete batch records, forms, and documentation.

At all times, understand and comply with quality standards and safety guidelines.

Perform materials stocking, kit preparation, reagent preparation, cleaning activities, and equipment maintenance.

Identify errors and report them promptly to lab management. Participate in root cause analysis and implement corrective actions.

Adhere to Good Manufacturing Practices (GMP) and Standard Operating Procedures (SOPs), including Good Documentation Practices (GDP).

Qualifications:

Bachelor’s degree in biology, chemistry, or related technical field, or equivalent industry experience.

0-2 years of experience in biopharmaceutical based GMP manufacturing operations, including experience in cell culture, and associated downstream processing is preferred.

Demonstrated technical knowledge of aseptic processing in cleanroom environments is preferred.

Ability to accurately perform basic math, including fractions, decimals, and percentages.

Ability to work effectively with team members and show initiative to assist others on the team when needed

Ability to work successfully in a fast-paced team-oriented environment.

Quality mindset, familiar with 21 CFR Part 11 and standard GxP best practices and FDA regulations.

Schedule:

Training will take place M-F on standard day shift for the first 6-8 weeks.

After that, the shift will be M-F from 5pm to 1:30am.

About Actalent:

Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We’re supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.