General Responsibilities:
Responsible for performing a variety of tasks in support of the daily production of sterile cell therapy products. Tasks are predominately performed within a cleanroom environment under current Good Manufacturing Practices (cGMP) conditions.
Responsibilities:
- Proficient in aseptic processing including media exchanges vessel passaging harvest & cryopreservation of cells as required by the daily production schedule.
- Ability to complete and maintains aseptic gowning qualification aseptic process qualification and cleaning & disinfection qualification.
- Perform media and reagent preparation duties as required.
- Ability to operate and maintain equipment.
- Perform equipment preventative maintenance cleaning/disinfection and basic troubleshooting as required.
- Perform record and report various inventory tasks (i.e. consumables media cryovial etc.
- Ability to train others on support tasks basic SOPs equipment and process operations.
- Achieves PowerUser status on supporting electronic systems (i.e. MasterControl).
- Follows revises executes and authors SOPs and MBRs in accordance with cGMPs.
- Ability to open and review documentation and MBRs at a high level.
- Ability to author and close quality items.
- Ability to initiate simple change controls and manage tasks required.
- Assists with material procurement and receipt.
- Maintains orderly and timely records of samples and data in accordance with company policy and legal requirements.
- Manages time well and multi-tasks to complete all assignments and responsibilities with supervisors 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.
- Maintains orderly and timely records of samples and data in accordance with company policy and legal requirements.
Computer Skills:
- Use of basic Microsoft applications efficiently.
- Contribute to SOP/BR generation and revision quality investigations Corrective/Preventative Action initiatives and Change Control procedures.
Qualifications :
Education:
- Minimum Bachelor of Science degree in a scientific discipline (or equivalent industry experience)
Experience:
- 2 years of 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 a cleanroom environment.
- Proficient in Manufacturing Process.
- Knowledge of 21CFR Part 11 standard GxP best practices and other industry standards.
- Proficient in Mammalian cell biology
- 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 thats making a difference in science every day.
Eurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.
Remote Work :
No
Employment Type :
Full-time
General Responsibilities:Responsible for performing a variety of tasks in support of the daily production of sterile cell therapy products. Tasks are predominately performed within a cleanroom environment under current Good Manufacturing Practices (cGMP) conditions.Responsibilities:Proficient in ase...
General Responsibilities:
Responsible for performing a variety of tasks in support of the daily production of sterile cell therapy products. Tasks are predominately performed within a cleanroom environment under current Good Manufacturing Practices (cGMP) conditions.
Responsibilities:
- Proficient in aseptic processing including media exchanges vessel passaging harvest & cryopreservation of cells as required by the daily production schedule.
- Ability to complete and maintains aseptic gowning qualification aseptic process qualification and cleaning & disinfection qualification.
- Perform media and reagent preparation duties as required.
- Ability to operate and maintain equipment.
- Perform equipment preventative maintenance cleaning/disinfection and basic troubleshooting as required.
- Perform record and report various inventory tasks (i.e. consumables media cryovial etc.
- Ability to train others on support tasks basic SOPs equipment and process operations.
- Achieves PowerUser status on supporting electronic systems (i.e. MasterControl).
- Follows revises executes and authors SOPs and MBRs in accordance with cGMPs.
- Ability to open and review documentation and MBRs at a high level.
- Ability to author and close quality items.
- Ability to initiate simple change controls and manage tasks required.
- Assists with material procurement and receipt.
- Maintains orderly and timely records of samples and data in accordance with company policy and legal requirements.
- Manages time well and multi-tasks to complete all assignments and responsibilities with supervisors 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.
- Maintains orderly and timely records of samples and data in accordance with company policy and legal requirements.
Computer Skills:
- Use of basic Microsoft applications efficiently.
- Contribute to SOP/BR generation and revision quality investigations Corrective/Preventative Action initiatives and Change Control procedures.
Qualifications :
Education:
- Minimum Bachelor of Science degree in a scientific discipline (or equivalent industry experience)
Experience:
- 2 years of 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 a cleanroom environment.
- Proficient in Manufacturing Process.
- Knowledge of 21CFR Part 11 standard GxP best practices and other industry standards.
- Proficient in Mammalian cell biology
- 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 thats making a difference in science every day.
Eurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.
Remote Work :
No
Employment Type :
Full-time
View more
View less