Eurofins USA PSS Insourcing Solutions
Cell Therapy Manufacturing Support
Eurofins USA PSS Insourcing Solutions, Exton, Pennsylvania, United States, 19341
Job Description
Responsible for performing a variety of tasks in support of the daily production of sterile cell therapy products. Tasks are predominantly performed within a cleanroom environment under current Good Manufacturing Practices (cGMP) conditions.
Responsibilities
Proficient in aseptic technique concepts.
Ability to complete and maintain aseptic gowning qualification, aseptic process qualification, and cleaning & disinfection qualification.
Perform aseptic processing, including media exchanges, vessel passaging, harvest & cryopreservation of cells as required by the daily production schedule.
Perform media and reagent preparation duties as required.
Ability to operate and maintain equipment.
Perform equipment preventative maintenance and cleaning/disinfection as required.
Basic User trained on electronic support systems (i.e. BMRAM, MasterControl, etc.)
Perform, record, and report various inventory tasks (i.e., consumables, media, cryovials, etc.)
Follows, revises, and executes SOPs and WBRs in accordance with cGMPs.
Collects and records scientific and process data per good documentation practices (GDPs).
Participates in quality event investigations by providing accurate information.
Assists with the receipt and organization of materials.
Maintains orderly and timely records of samples and data, in accordance with company policy and legal requirements.
Manages time well and multitasks to complete all assignments and responsibilities with the supervisor’s guidance.
Maintains a safe working environment for self and others, including work area cleanliness.
Monitors resources and enforces SOPs to ensure data integrity and compliance with industry.
Participates in process optimization and continuous improvement opportunities.
Computer Skills
Use of basic Microsoft applications efficiently.
Contribute to SOP/BR generation and revision, quality investigations, Corrective/Preventive Action initiatives, and Change Control procedures.
Qualifications Education
Minimum Bachelor of Science degree in a scientific discipline (or equivalent industry experience)
Experience
1 year experience in mammalian cell culture in an academic or industrial laboratory
Knowledge of basic laboratory skills (aseptic technique, pipetting, etc.) are required.
Must be comfortable with performing tasks while fully gowned in an aseptic cleanroom environment.
Knowledge of 21CFR Part 11, standard GxP best practices and other industry standards.
Mammalian cell biology experience is considered a plus.
Excellent verbal and written skills.
Good interpersonal communication skills.
Must be willing to work weekends, evenings, and holidays (as needed).
Additional Information What to Expect in the Hiring Process
10-15 Minute Phone Interview with Region Recruiter
45-60 Minute Virtual Interview with Manager and/or Group Leader
Additional Details This is a full‑time, onsite position based on a first‑shift schedule (Monday through Friday, 8:00am to 5:00pm), with overtime required as needed. Candidates located within a commutable distance to Exton, PA are strongly encouraged to apply.
Excellent full-time benefits include
comprehensive medical coverage, dental, and vision options
Life and disability insurance
401(k) with company match
Paid vacation and holidays
Ready to take the next step in your career? Apply today and join a team that’s making a difference in science every day.
Eurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.
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Responsibilities
Proficient in aseptic technique concepts.
Ability to complete and maintain aseptic gowning qualification, aseptic process qualification, and cleaning & disinfection qualification.
Perform aseptic processing, including media exchanges, vessel passaging, harvest & cryopreservation of cells as required by the daily production schedule.
Perform media and reagent preparation duties as required.
Ability to operate and maintain equipment.
Perform equipment preventative maintenance and cleaning/disinfection as required.
Basic User trained on electronic support systems (i.e. BMRAM, MasterControl, etc.)
Perform, record, and report various inventory tasks (i.e., consumables, media, cryovials, etc.)
Follows, revises, and executes SOPs and WBRs in accordance with cGMPs.
Collects and records scientific and process data per good documentation practices (GDPs).
Participates in quality event investigations by providing accurate information.
Assists with the receipt and organization of materials.
Maintains orderly and timely records of samples and data, in accordance with company policy and legal requirements.
Manages time well and multitasks to complete all assignments and responsibilities with the supervisor’s guidance.
Maintains a safe working environment for self and others, including work area cleanliness.
Monitors resources and enforces SOPs to ensure data integrity and compliance with industry.
Participates in process optimization and continuous improvement opportunities.
Computer Skills
Use of basic Microsoft applications efficiently.
Contribute to SOP/BR generation and revision, quality investigations, Corrective/Preventive Action initiatives, and Change Control procedures.
Qualifications Education
Minimum Bachelor of Science degree in a scientific discipline (or equivalent industry experience)
Experience
1 year experience in mammalian cell culture in an academic or industrial laboratory
Knowledge of basic laboratory skills (aseptic technique, pipetting, etc.) are required.
Must be comfortable with performing tasks while fully gowned in an aseptic cleanroom environment.
Knowledge of 21CFR Part 11, standard GxP best practices and other industry standards.
Mammalian cell biology experience is considered a plus.
Excellent verbal and written skills.
Good interpersonal communication skills.
Must be willing to work weekends, evenings, and holidays (as needed).
Additional Information What to Expect in the Hiring Process
10-15 Minute Phone Interview with Region Recruiter
45-60 Minute Virtual Interview with Manager and/or Group Leader
Additional Details This is a full‑time, onsite position based on a first‑shift schedule (Monday through Friday, 8:00am to 5:00pm), with overtime required as needed. Candidates located within a commutable distance to Exton, PA are strongly encouraged to apply.
Excellent full-time benefits include
comprehensive medical coverage, dental, and vision options
Life and disability insurance
401(k) with company match
Paid vacation and holidays
Ready to take the next step in your career? Apply today and join a team that’s making a difference in science every day.
Eurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.
#J-18808-Ljbffr