Associate Manufacturing Nights

Role Summary

Associate Manufacturing Nights

In this role you will perform operations in the Manufacturing area under general supervision, following SOPs. You will work a 12-hour rotating night shift (7PM-7AM) with a 2-6 week administrative onboarding period (Mon-Fri, 8am-5pm).

Responsibilities

• Perform and monitor critical processes, complete routine validation protocols, and draft/revise Manufacturing Procedures, SOPs, and technical reports.
• Perform basic troubleshooting and assist in the review of documentation for assigned functions.
• Participate on cross-functional teams and represent Manufacturing.
• Possibly own NC/CAPA items and identify, recommend, and implement improvements related to routine functions.

Qualifications

• Basic:
  • High school/GED + 2 years of manufacturing or operations experience OR
  • Associate’s + 6 months of manufacturing or operations experience OR
  • Bachelor’s degree
• Preferred:
  • Knowledge of single-use Biomanufacturing technology
  • CFR and Regulatory knowledge
  • Mechanical ability/expertise
  • Knowledge of lab equipment and computers
  • Basic statistical mathematical skills
  • Ability to interpret and apply GMP knowledge
  • Understanding of analytical methods for manufacturing area
  • Technical writing capability
  • Project management and presentation skills
  • Understanding of basic chemistry, biology and physical principles
  • Basic troubleshooting skills
  • Experience with Delta V and RD’s
  • Experience with lab equipment/testing

Skills

• Technical writing
• Analytical thinking
• Problem solving
• Cross-functional collaboration
• Project management

Education

• High school diploma or equivalent required; degrees as listed in qualifications

Additional Requirements

• 12-hour night shift with differential and Sunday premium pay
• Onboarding schedule may be administrative (Mon-Fri, 8am-5pm) for 2-6 weeks