Responsible for cGMP Upstream manufacturing operations at the Viral Vector Services Thermo Fisher Scientific Lexington, MA
Executing aseptic operations within a biosafety cabinet and cleanroom environment.
Performing operations in an aseptic seed lab, operating Wave bioreactors, operating adherent / stir tank bioreactors.
Good Documentation Practices for all activities within controlled batch documentation (Batch Records, Logbooks, Forms, Etc.)
Follows verbal and written procedures in operating production equipment and performing processing steps; accurately completes appropriate production documentation.
Identifies, escalates and documents events and subtle variances that deviate from normal operation; participate as needed in investigations.
Monitor processes using automated / semi-automated production systems and controls with limited supervision.
Equipment preparation, sanitation and disinfection.
Demonstrates ability to troubleshoot basic biotechnical operations.
Work in accordance with site and company EHS programs.
Work in accordance with regulations, detailed protocols, Batch Record's, SOP's and Work Instructions.
The incumbent will onboard and support project activities Monday through Friday, 8:00 AM to 5:00 PM. The position will transition to a 12-hour day rotational shift as the site becomes operational.
May require overtime to work evenings, weekends or holidays, as required to meet project timelines. Requirements:
Must be able to work in a fast-paced environment.
A strong attention to detail.
Solid understanding of aseptic principles.
Work towards solutions to given problems and operate under cGMP requirements.
Work cross-functionally with support groups such as Facilities, Engineering, Contamination Control, Quality Control and Quality Assurance.
Qualify to work in aseptic environments to complete required production activities.
Maintain facility and room inspection readiness.
Ability to lift at least 50lbs.
Ability to aseptically gown and/or sterile gown as needed.
Knowledge, Skill and Requirements
Bachelor's Degree with 1-3 years of industry related experience in cGMP manufacturing.
High School diploma and 2-4 years' industry related experience in cGMP manufacturing.
Independently motivated and can work within a cross-functional team
Bachelor's Degree with 2-4 years of Upstream experience in cGMP manufacturing.
High School diploma with 3-5 years of Upstream experience in cGMP manufacturing.
Note: This job description is not all-inclusive. Additional duties may be performed, as assigned. It acts as a guideline and is subject to change over time. If you are an individual with a disability who requires reasonable accommodation to complete any part of our application process, click here for further assistance.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legal protection
Posting ID: 558255763Posted: 2020-05-21