Contract to hire
*MUST have GMP cell/gene experience, ISO7 experience and must be clear in resume*
AMTII: all start at $31.75 an hour
Sr. AMTs: all start at $35.00 an hour
Leads: all start at $40.00 an hour
Schedule:
Wednesday - Saturday or Sunday - Wednesday. 4x10 and 3x12 (schedule rotates from week to week). Start time around 7:30 AM (works out best if you are open to both shifts as we may only need to fill a particular shift by the time we receive your resume/interview)
Description:
Aseptic Manufacturing Technicians are required to work their assigned schedule. The first few months of onboarding training for this position will occur during regular work week hours (1st shift M-F); however, once the technician is trained, they will be assigned to a shift that include weekends, evenings, and holidays, as needed (i.e. Shifts may be Sunday to Wednesday, Wednesday to Saturday). May be required to work overtime.
Essential Functions and Responsibilities:
• Develop a Subject Matter Expert (SME)-level understanding of and be able to skillfully lead, oversee and execute as well as troubleshoot GMP cell therapy manufacturing process(es).
• Subject matter expert (SME) responsible for ensuring and enforcing strict adherence to proper aseptic technique among all team members.
• Ensures aseptic operations within grade A Biological Safety Cabinet (BSC) functions are strictly followed, such as:
o Manipulations within the BSC.
o Aseptic liquid transfer.
o Measures and weighs for in-process materials.
• Responsible for ensuring all activities on assigned operations are complete and executed in a compliant manner. (i.e., Batch record review, flask handling and storage, final product inspections, cryopreservation, inventory management system transactions, chain of information, chain of custody transactions, materials stocking and transfer, kit preparation, and room readiness.
• Ensures the team understands, adheres and complies with Safety SOPs, SDS sheets, current Good Manufacturing Practices (cGMP), Standard Operating Procedures (SOPs), including Good Documentation Practices (GDP) and laboratory procedures per company policy and OSHA regulations.
• Assist supervisor(s) and coordinator to ensure adherence to production schedule while maintaining internal production priorities.
• Complete tier 1 KPI reporting form at end of shift.
• Attend or drive the daily Tier 1 meeting in the absence of a supervisor or as required and escalate issues/concerns at that forum to Area Management for further investigation.
• Triages equipment troubleshooting and any other escalations.
o Clearly and timely communicates and escalates to the proper support team (i.e., QO, Operations Supervisor, Specialist, Area Manager).
• Primary Responsibilities:
o Grade A/ISO 5, BSC grade B/ISO 7/Bench:
Oversees, and provides training for in-suite operational functions.
o Hallway and Preps:
Oversees, and provides training for hallway and preps operational functions.
Miscellaneous
• Assists with identifying training needs, establishing a feedback loop to ensure continuous improvement.
• Ensure mathematical calculations are done accurately.
• Ensures aseptic tube welding, sealing and connections are done correctly.
• Ensure all in-process samples are collected and submitted.
• Ensure all executed records are complete and accurate.
• Ability to lead, organize, execute, and work in a team environment and independently as required.
• Works on routine assignments per written procedures, where the ability to recognize deviation from accepted practice is required.
• Leadership acumen, ability to prioritize, proactive, results oriented, self-starter with experience in a complex manufacturing environment.
• Perform miscellaneous duties as assigned.
• Able to train, pass and maintain gowning qualification.
• Able to train, pass and maintain APQs (Aseptic Process Qualifications).
• Performs documentation needs, which include drafting and reviewing of SOPs, Work Instructions, Forms, Batch Records, Deviations, CAPAs, etc.
• Facilitate comprehensive training sessions as a certified trainer. Ensure clear, concise guidance and maintain meticulous training documentation, adhering to strict Good Documentation Practices (GDPs).
• Identifies training gaps and needs, establishing a feedback loop to ensure continuous improvement.
• Support departmental projects in a contributor capacity.
• To be trained in all different roles
Required Education, Skills, and Knowledge
• Bachelor's degree or relevant experience.
• Minimum 3+ years of experience in biopharmaceutical-based GMP manufacturing operations, including, aseptic technique, aseptic liquid transfers, use of welders and sealers, BSC aseptic operations and associated downstream processing is a plus.
• Ability to oversee, lead and drive cleanroom activities while building relationships quickly and credibly
• Ability to perform arithmetic calculations accurately and reproducibly, including fractions, decimals, percentages, and basic algebraic and geometric calculations.
• SME demonstrated a level of understanding and technical knowledge of aseptic processing in cleanroom environments is a must.
• Ability to oversee floor operations, mentor and provide best practices to all levels of technicians.
• Must be able deal with ambiguity – ready to change gears and plans quickly, able to manage constant change.
• Must be able to read, write and understand English especially for Good Documentation Practices, and be proficient in Microsoft (Excel, Word, Outlook and Teams).
• Ability to work successfully in a fast-paced team-oriented environment and independently as required
Preferred Education, Skills, and Knowledge
• Minimum 3+ years of experience in biopharmaceutical-based GMP manufacturing operations, including experience in cell culture and associated downstream processing, including but not limited to cell culture, single use high density bioreactors, Bio Safety Cabinets (BSCs), cell count machines, liquid transfers, cell wash and concentration machines, tube welders and sealers, controlled rate freezers, grade B (ISO7) gowning and liquid nitrogen amongst others.
• Leadership and Quality mindset, familiar with 21 CFR Part 11, standard GxP best practices and FDA regulations.
The physical demands described here represent those that an employee must meet to perform the essential functions of this job successfully. Reasonable accommodation may be made upon request to enable individuals to perform essential functions. Please contact Human Resources to request accommodation.
For the Visual Inspection Program, the technician must be able to pass a Vision Exam that includes the following:
• Must not be color blind.
• Must have 20/20 near vision in both eyes (can be corrected)
• Clarity of vision at near and mid-range, depth perception, and ability to identify and distinguish colors may be given a visual exam for visual acuity and color perception.
Physical Demands and Activities Required:
• You must be able to wear appropriate cleanroom attire and all Personal Protective Equipment (PPE), i.e., scrubs, gowning coveralls, masks, gloves, etc.
• You must meet requirements for and be able to wear a half-faced respirator.
• Able to stand and/or walk 90% (and sit 10%) within your scheduled workday, which may include climbing ladders or steps.
• Able to work in a cleanroom with biohazards, human blood components, and chemicals.
• Able to crouch, bend, twist, reach, and perform activities with repetitive motion.
• You must be able to lift and carry objects weighing up to 50 pounds.
Mental:
• Clear and conceptual thinking ability; excellent judgment, troubleshooting, problem-solving, analysis, and discretion; ability to handle work-related stress; ability to handle multiple priorities simultaneously; and ability to meet deadlines.
Work Environment:
• This position will work in both an office and a manufacturing setting.
• When in the cleanroom setting, you must be able to work with various chemical/biochemical exposures, including latex and bleach.
• Potential exposure to noise and equipment hazards and strong odors.
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