Manufacturing Associate l

Role Summary

As a Manufacturing Associate I, you will perform daily manufacturing operations according to SOPs in a cGMP environment. You will operate biologics production equipment (bioreactors, filtration units, chromatography systems and fixed/portable vessels) and will complete validation protocols. You will report to the Manufacturing Supervisor. Location: Brooklyn Park, MN.

Responsibilities

• 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.
• With general management or guidance will assemble and operate biologics production equipment, such as bioreactors, filtration units, chromatography systems and fixed/portable vessels.
• Perform basic troubleshooting.
• Document cGMP data for processing steps and equipment activities while following standard operating procedures. Main documentation includes batch records, work orders, and equipment logbooks.
• With general management perform/or assist with processing steps and manufacturing support activities by managing process parameters in batch record and control systems.
• You will complete batch records and validation protocols under management/direction of others.
• Review equipment use logs with support.
• Perform inventory transactions in SAP.
• Perform data entry into LIMS.
• Perform cleaning/sanitizing production equipment.

Qualifications

• High school diploma or GED.
• Experience in GMP environment would be ideal.
• Associates degree or higher in a scientific discipline would be ideal.
• Understanding of current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP) would be ideal.
• Knowledge of non-manufacturing functions such as QC, Regulatory, QA, and Materials Management would be ideal.
• Prior experience with lab equipment would be ideal.
• Knowledge of mathematical calculations (addition, subtraction, division, multiplication) and rounding.
• Can perform basic computer operations, such as ability to navigate in MS Office, use email, and complete training using Web-based Training (WBT).
• Familiar or experience with cGMP within Biotech or Pharmaceutical operations would be ideal.

Education

• Associates degree or higher in a scientific discipline would be ideal.

Additional Requirements

• 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.
• Need to remove all make-up, jewelry, contact lenses, nail polish or artificial fingernails while in the manufacturing environment.
• Work in a cold, wet environment.
• Work multiple shifts, including weekends, or be asked to work supplemental hours.
• Work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.
• Stand and Walk - Required to stand/walk while operating manufacturing/computer equipment for several hours at a time daily.
• Carry weight, Pushing, Pulling Lifting - Required to carry, lift, push, and 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.
• Move 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).
• On rare occasions, travel may be required to offsite meetings or training event.