Manufacturing Associate I - Night 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 night shift role with a rotating schedule, and working hours are from 5:45 PM to 6:15 AM.

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 SOPs; main documentation includes batch records, work orders, and equipment logbooks.
• With general management, 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 or direction of others.
• Review equipment use logs with support.
• Perform inventory transactions in SAP.
• Enter data into LIMS.
• Perform cleaning and sanitizing of production equipment.

Qualifications

• Required: Knowledge of mathematical calculations (addition, subtraction, division, multiplication) and rounding.
• Required: Ability to perform basic computer operations, such as navigating MS Office, using email, and completing Web Based Training (WBT).
• 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.
• Preferred: Familiar or experience with cGMP within Biotech or Pharmaceutical operations.

Education

• High school diploma or GED
• Associates degree or higher in a scientific discipline (Preferred)

Additional Requirements

• May be required to wear personal protective equipment (PPE) and other clean room garments daily, including safety shoes, safety glasses, aprons, face shields, lab coats, full body gowns, hair nets, gloves and hearing protection.
• Remove makeup, jewelry, contact lenses, nail polish and/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, as necessary.
• Work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.
• Stand and walk for several hours at a time while operating manufacturing/computer equipment.
• Carry, lift, push, and/or pull up to 50 pounds several times a day for 15-minute durations.
• Climb stairs/step ladders several times a day for 15-minute durations.
• Bend, kneel, or crawl several times a day for 15-minute durations.
• Overhead reaching during handling of production materials/files/supplies several times a day for 15-minute durations.
• Move head and neck while using computer applications and handling production equipment and materials several times a day for several hours at a time.
• Twist or rotate waist several times a day for several hours at a time.
• 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 the assigned shift (day or night).
• On rare occasions, travel may be required to offsite meetings or training events.