Reports To (Position Title):
Manufacturing Supervisor or Higher
- Supports manufacturing department by utilizing equipment such as washers, autoclaves and material handling tools to prepare equipment and materials for the manufacturing process.
- Performs and documents, according to SOP s, cGMP activities to support manufacturing operations. This involves operation of equipment, execution of validation protocols, and completion of cGMP documents
- Performs Manufacturing Support activities such as equipment preparation and weigh and dispense of materials.
- Documents/Records cGMP data and information for equipment activities while following standard operating procedures (SOP s). Key documentation includes validation protocols and equipment logbooks.
- Perform dispensing, labeling and transferring/staging of raw materials and parts
- Will assemble/disassemble, clean and sterilize components, parts and equipment
- Maintain equipment, area and cleaning logbooks
- Stock production and cleaning supplies
- Accountable for completing assigned trainings within required timeline and actively participate in training activities
- Performs inventory transactions in SAP
- Other duties as assigned
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
- High School Diploma or GED
- 1-2 years relevant experience preferred.
Knowledge, competencies and skills:
- Knowledge of current Good Manufacturing Practices (cGMP s) and Good Documentation Practices (GDP) preferred.
- Must be team and detail-oriented and able to work in a fast-paced environment
- Possess good written and oral communication skills.
- Knowledge of non-manufacturing functions such as QC, Regulatory, QA, and/or Materials Management a plus.
- Basic equipment understanding, including understanding equipment function and application a plus.
PHYSICAL DEMANDS: (Identify any physical demands required in the performance of the primary responsibilities of the position).
- Stand and Walk - Required to stand/walk while operating manufacturing/computer equipment for several hours at a time daily.
- Carrying weight, Pushing, Pulling and 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 includes: safety shoes, safety glasses, aprons, face shields, lab coats, full body gowns, hair nets and gloves. Occasionally will need to wear hearing protection.
- On rare occasions, travel may be required to offsite meetings or training event
Brooklyn Park, MN