Aseptic Processing Technician (1st shift)
700 Spring Garden St. Philadelphia, PA 19123 US
Job Description
Overview
As an Aseptic Processing Technician, you will focus on the documentation for our processes. The ideal candidate will have a background in cell culture, aseptic gowning and qualification, and ISO class 5 cleanroom operations. This position works across different shifts. Depending on your assigned shift, you may be required to work overtime, weekends, and holidays to ensure the manufacturing process is completed.
This is a 1st shift position working a 4 day week - Tuesday - Friday 7am - 5pm
Essential Functions and 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.
• Adheres to Good Manufacturing Practices (GMP) and Standard Operating Procedures (SOPs), including Good Documentation Practices (GDP).
• Must adhere to core values, policies, procedures, and business ethics.
• Comply with Safety SOPs, SDS sheets, and laboratory procedures per company policy and OSHA regulations.
• Perform miscellaneous duties as assigned.
Travel - Up to 5% of travel
Required Education, Skills, and Knowledge
• Minimum AS degree in biology, biochemistry, bioengineering, 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.
• Able to read, write and understand English, and be proficient in Microsoft (Excel, Word, Outlook).
• Able to accurately perform basic math, including fractions, decimals, and percentages.
• Able to work effectively with team members and show initiative to assist others on the team.
• Able 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.
Preferred Qualifications:
• Demonstrated technical knowledge of aseptic processing in cleanroom environments.
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