Manufacturing Associate I - Day Shift

Role Summary

As a Manufacturing Associate I, you will perform and document 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 execute validation protocols. You will report to the Manufacturing Supervisor. This is a day shift role with a rotating schedule.

Responsibilities

• Perform dispensing, labeling, and transferring/staging of raw materials and parts.
• Assemble/disassemble, clean, and sterilize components, parts, and equipment.
• Maintain equipment, area, and cleaning logbooks.
• Assemble and operate biologics production equipment, such as bioreactors, filtration units, chromatography systems and fixed/portable vessels, with general management or guidance.
• Perform basic troubleshooting.
• Document cGMP data for processing steps and equipment activities following standard operating procedures; main documentation includes batch records, work orders, and equipment logbooks.
• Assist with processing steps and manufacturing support activities by managing process parameters in batch records and control systems.
• Execute batch records and validation protocols under management/direction of others.
• Review equipment use logs with support.
• Perform inventory transactions in SAP.
• Enter data into LIMS.
• Perform cleaning/sanitizing of production equipment.

Qualifications

• Required: High school diploma or GED.
• Preferred: Experience in GMP environment.
• Preferred: Associates degree or higher in a scientific discipline.
• Preferred: Understanding of current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP).
• Preferred: Knowledge of non-manufacturing functions such as QC, Regulatory, QA, and/or Materials Management.
• Preferred: Prior experience with lab equipment.
• Required: Knowledge of mathematical calculations (addition, subtraction, division, multiplication) and rounding.
• Required: Ability to perform basic computer operations (MS Office, email) and complete Web Based Training (WBT).
• Preferred: Familiarity or experience with cGMP within Biotech or Pharmaceutical operations.

Additional Requirements

• May be required to wear PPE and other clean room garments daily (safety shoes, safety glasses, aprons, face shields, lab coats, gowns, hair nets, gloves, hearing protection).
• Remove make-up, jewelry, contact lenses, nail polish, and artificial nails in manufacturing environment.
• Work in a cold, wet environment.
• Work multiple shifts, including weekends, or supplemental hours as necessary.
• Work around chemicals requiring respiratory protection.
• Stand and walk for extended periods; carry, lift, push, and pull up to 50 pounds several times daily.
• Climb, bend, kneel, and perform overhead reaching several times daily.
• Move head/neck, twist, and perform repetitive use of arms and wrists during equipment setup.
• Must be able to work assigned shift (day or night).
• Occasional travel to offsite meetings or training events may be required.