Manufacturing Associate I

About the role

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 complete validation protocols. 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.
• Perform basic troubleshooting.
• Document cGMP data for processing steps and equipment activities, including batch records, work orders, and equipment logbooks.
• Perform or assist with processing steps and manufacturing support activities by managing process parameters in batch records and control systems.
• Complete batch records and validation protocols under management direction.
• Review equipment use logs with support.
• Perform inventory transactions in SAP.
• Perform data entry into LIMS.
• Perform cleaning and sanitizing of production equipment.

Requirements

• High school diploma or GED.
• Experience in a GMP environment is ideal.
• Associate’s degree or higher in a scientific discipline is ideal.
• Understanding of current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP) is ideal.
• Knowledge of non-manufacturing functions such as QC, Regulatory, QA, and Materials Management is ideal.
• Prior experience with lab equipment is ideal.
• Familiarity or experience with cGMP within Biotech or Pharmaceutical operations is ideal.
• Knowledge of mathematical calculations (addition, subtraction, division, multiplication) and rounding.
• Ability to perform basic computer operations, such as navigating MS Office, using email, and completing web-based training.
• Required to wear personal protective equipment (PPE) and other cleanroom garments, including safety shoes, safety glasses, aprons, face shields, lab coats, full-body gowns, hair nets, gloves, and hearing protection.
• Must remove all makeup, jewelry, contact lenses, nail polish, or artificial fingernails while in the manufacturing environment.
• Ability to work in a cold, wet environment.
• Ability to work multiple shifts, including weekends, or be asked to work supplemental hours.
• Ability to work around chemicals such as alcohol, acids, buffers, and Celite that may require respiratory protection.
• Physical requirements:
  • Stand and walk for several hours at a time while operating manufacturing/computer equipment.
  • Carry, lift, push, and pull up to 50 pounds several times a day for 15-minute durations.
  • Climb (use of stepladders/stairs) several times a day for 15-minute durations.
  • Bend, kneel, or crawl several times a day for 15-minute durations.
  • Perform overhead reaching several times a day for 15-minute durations.
  • Move head and neck frequently while using computer applications and handling production equipment.
  • Twist waist while setting up equipment 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.
• Ability to work assigned shift (day or night).
• On rare occasions, travel may be required to offsite meetings or training events.

Pay

U.S. hourly wage range: $19.81 – $31.10. The actual hourly wage offered may depend on qualifications, experience, skills, education, location, and other factors.

Benefits

• Eligibility for short-term incentives.
• Medical, dental, and vision insurance.
• 401(k) plan with company match.
• Short-term and long-term disability coverage.
• Basic life insurance.
• Tuition reimbursement program.
• Paid volunteer time off.
• Company holidays.
• Well-being benefits.
• Up to 80 hours of sick time per calendar year.
• New hires eligible to accrue up to 120 hours of paid vacation per calendar year.

Schedule

Working hours: 5:45 AM to 6:15 PM, day shift with a rotating schedule.