Thermo Fisher Scientific Production Technician 1 in St. Louis, Missouri
The candidate will be responsible for the performance of operations in support of the manufacture of Commercial and Clinical Biologics. Candidate will be responsible for following current Good Manufacturing Practices (cGMP) and carrying out a variety of functions related to Downstream (purification) biopharmaceutical manufacturing. These functions may include but are not limited to activities such as conducting large scale chromatography, viral inactivation, viral inactivation, ultrafiltration and diafiltration, as well as aseptic filling of bulk drug substance.
Eligible candidates will need to be available to work second shift.
Execution of manufacturing batch records, work instructions and/or SOP's, with focus on 'right the first time' executions. Able to assist in all department functions, such as maintaining suite, supplies equipment, logbooks and data in accordance with site SOP's and policies. Documentation of all activities to meet cGMP requirements. Execute document reviews and revisions. Daily record review, tasks, and databases. Actively provides feedback.
Capable of reading PID’s and deciphering equipment lineouts used in performing routine activities within each manufacturing area.
Disassemble, clean and reassemble production equipment as necessary in preparation for batch processing.
Conduct pre-processing staging of equipment and/or raw materials for batch startup as outlined within operating instructions.
Critical evaluation of processes, including foresight and thinking ahead
Complete preventative maintenance and work notifications tasks on time. Performs equipment testing and routine trouble-shooting.
Ensure tasks are executed with a method of prioritization - interpret production schedules and complete tasks accordingly. Participate in shift exchanges, 1-1 meetings, attend meetings as necessary to facilitate area needs based on changes, etc. (lean activities or PPI)
Monitor and record critical process parameters as specified within the operating instructions.
Follows all documentation procedures assuring that paperwork are in accordance with all company and regulatory standards.
Regularly completes tasks as assigned to meet production schedules.
Responsible for keeping the working area in a clean, neat and orderly manner at all times. Must be able to efficiently work while observing all safety procedures.
Ensure chemicals used are properly stored and labeled.
Maintains appropriate relations with coworkers.
High school diploma required. Bachelor’s degree preferred (Biology, Biochemistry, Chemistry, Chemical Engineering, or similarly related field)
0-1 Years of relevant GMP lab experience in a related field or industry preferred
Solid communication skills in English.
Ability to perform mathematical operations using US and metric units of weight, volume and time.
Assigned uniform, protective gloves, safety glasses with side shields, and safety shoes; other personal protective equipment (PPE) may be required at times.
Ability to use simple hand tools.
Ability to read and comprehend instructions, short correspondence, and memos.
Ability to read and interpret documents such Standard Operating Procedures (SOP).
Ability to effectively present information and respond to questions.
Ability to recognize and locate required information. Strong observation skills; ability to use an iPad, PC and software.
If you are an individual with a disability who requires reasonable accommodation to complete any part of our application process, click here at https://jobs.thermofisher.com/page/show/eeo-affirmative-action-statement#accessibility 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 legally protected status.