Aseptic Manufacturing Technician I/II/Senior/Lead

Aseptic Manufacturing Technician (AMT) - Levels I/II/Senior/Lead

Employment Type: Contract-to-hire with potential for full-time status; eligible for overtime

Location: Onsite in Philadelphia, PA

Compensation & Shift Details:

• AMT I: $27-28/hour (Contract-to-Hire) | 0-1 years of experience
• AMT II: $30-31/hour (Contract-to-Hire) | $32/hour if converted to FTE | 1-2 years of experience
• Senior AMT: $35/hour (Full-Time Employee) | 2-3 years of experience
• Lead AMT: $40/hour (Full-Time Employee) | 3 years of experience

Shift Differential: 10-15% additional pay (exact rate to be confirmed)

Shift: 1st, 2nd, & 3rd

Overview:

This client is seeking highly skilled Aseptic Processing Technicians at various levels (Lead, Senior, Supervisor) to join our team at our GMP-compliant facility in Philadelphia, PA. This role involves working within ISO 7 cleanrooms and ISO 5 biological safety cabinets, handling critical raw materials used in cell therapy manufacturing. Candidates will be trained initially on the day shift (Mon-Fri) for 12 weeks before transitioning to respective shift. There will be opportunities for contract-to-hire conversions and potential relocation/sign-on bonuses for strong candidates.

Key Responsibilities:

Lead/Senior/Supervisor Specific:

• Lead or mentor team members, manage or supervise operations, and ensure team adherence to GMP practices.
• Provide expertise in training, documentation, deviations, CAPAs, SOPs, batch records, and change controls.
• Ensure compliance with quality standards, safety guidelines, and GMP regulations (including Good Documentation Practices and 21 CFR Part 11).
• Identify and report errors, participate in root cause analysis, and help implement corrective actions.

All Roles (APT I & II):

• Execute aseptic processes in a cleanroom environment, adhering to GMP and SOP standards.
• Accurately complete batch records and documentation for each lot produced.
• Perform duties including materials stocking, kit and reagent preparation, cleaning activities, and equipment maintenance.
• Troubleshoot, identify deviations, and collaborate with the team to resolve issues.
• Ensure compliance with safety SOPs, SDS sheets, and OSHA regulations.
• Complete training sessions and maintain all necessary documentation.
• Work in a fast-paced, team-oriented environment, ensuring all tasks are completed on schedule.

Qualifications:

Education & Experience:

• Lead/Senior/Supervisor roles: 2-3 years GMP industry experience (cell culture preferred). Experience in leadership or team management is required.
• APT I & II: Minimum AS degree in biology, biochemistry, or related field, or equivalent industry experience. 0-3 years of GMP cell or gene therapy manufacturing experience.
• Proficiency in Microsoft Office Suite (Excel, Word, Outlook).
• Familiarity with 21 CFR Part 11, GxP best practices, and FDA regulations.
• Excellent written and verbal communication skills in English.

Required Skills:

• Strong aseptic technique and knowledge of aseptic gowning and qualification.
• Experience in ISO class 5 cleanroom operations and cell culture/processing (downstream preferred).
• Ability to follow procedures and documentation accurately.
• Proactive attitude with the ability to work both independently and as part of a team.
• Strong organizational skills and attention to detail.
• Ability to handle ambiguity and adjust to changing priorities quickly.