- Perform and document daily manufacturing operations according to SOP s in a cGMP environment
- Operate biologics production equipment (bioreactors, filtration units, chromatography systems and fixed/portable vessels)
- Execute validation protocols
- Create or revise cGMP documents
- With general supervision or guidance will assemble and/or operate biologics production equipment, such as bioreactors, filtration units, chromatography systems and fixed/portable vessels.
- Perform basic trouble shooting
- Performs/assists with processing steps and/or manufacturing support activities by monitoring process parameters in batch record and control systems
- Documents cGMP data and information for processing steps and/or equipment activities while following standard operating procedures. Key documentation includes batch records, work orders, and equipment logbooks.
- Executes batch records and validation protocols under supervision/direction of others
- Author and review equipment use logs
- Performs inventory transactions in SAP
- Performs data entry into LIMS
- Accountable for completing assigned trainings within required timeline and actively participate in training activities.
- Stock production and cleaning supplies
- Perform cleaning/sanitizing production rooms and equipment
- Other duties as assigned
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
Preferred combination of education and experience:
- Bachelor s degree in Science or Engineering; or
- Associate s degree in science-related area and 1 or more years of relevant experience; or
- High school diploma or GED and 3 or more years of relevant experience.
- Experience in a regulated environment preferred
Knowledge, competencies and skills:
- Understanding of current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP) preferred
- Familiar or experience with cGMP within Biotech or Pharmaceutical operations preferred
- Knowledge of non-manufacturing functions such as QC, Regulatory, QA, and/or Materials Management a plus
- Prior experience with lab equipment a plus
- Knowledge of mathematical calculations (addition, subtraction, division, multiplication) and rounding.
- Must have excellent written and oral communication skills
- Must be team and detail-oriented and able to work in a fast-paced environment.
- Ability to perform basic computer operations, such as ability to navigate in MS Office, use email, and complete training using Web Based Training (WBT)
- Must be able to read and understand English
- Stand and Walk - Required to stand/walk while operating manufacturing/computer equipment for several hours at a time daily
- Carrying weight, Pushing, Pulling Lifting - Required to carry, lift, push, and/or pull up to 50 pounds several times a day for 15-minute durations while handling production equipment and/or materials
- Climb - Required to climb (use of stepladders/stairs in production areas, or stairwells in work campus) several times a day for 15-minute durations.
- Bend and Kneel - Required to bend, kneel, or crawl several times a day for 15-minute durations
- Overhead work - Required to perform overhead reaching during handling of production materials/files/supplies several times a day for 15-minute durations
- Moving Head and Neck Required movement of head/neck while using computer applications and handling of production equipment and materials several times a day for several hours at a time
- Twisting - Required movement of twisting waist while setting up equipment several times a day for several hours at a time
- Repetitive Use - Required repetitive use of arms and wrists while setting up equipment several times a day for several hours at a time
- Must have the ability to work assigned shift (day or night)
- Will be required to wear personal protective equipment (PPE) and other clean room garments daily. This may include: safety shoes, safety glasses, aprons, face shields, lab coats, full body gowns, hair nets and gloves and hearing protection
- On rare occasions, travel may be required to offsite meetings or training event
Brooklyn Park, MN