Manufacturing Associate DAY SHIFT

Position Overview

We have opportunities for Manufacturing Associates at several levels within our Drug Substance production teams who are willing and able to work on a DAY SHIFT (Approximately 7:00 AM – 7:00 PM).

These roles will execute manufacturing processing steps and associated activities when operational. Our facility will be 24/7 operational and our manufacturing teams work 12-hour shifts on a 2-2-3 calendar rotation.

Responsibilities:

• Execute and document manufacturing processing steps or support activities, process monitoring, and control within functional areas in manufacturing (e.g., Fermentation, Purification, Recovery, Cell Culture) and/or support functions (e.g., Glass wash, Buffer/Solution Prep).
• Perform in-process sampling and testing (e.g., pH, conductivity, visual inspection).
• Execute validation protocols according to Current Good Manufacturing Practice (CGMP) standard operating procedures (SOPs).
• Maintain training to perform all required activities.
• Perform manufacturing task execution using all applicable areas of Distributed Control Systems (DCS) (Delta V, 800xA, Unicorn, etc.).
• Conduct takeouts, identity check returns and other tasks in Manufacturing Execution System (MES).
• Perform clean-in-place (CIP), steam-in-place (SIP) and other equipment cleanings.
• Senior level technician roles are leaders within manufacturing operations and are additionally responsible for
  • Serving as a subject matter expert (SME) in core responsibilities for manufacturing assigned area.
  • Training and mentoring junior associates to enhance team capabilities.
  • Supporting scheduling of daily activities on the manufacturing floor, as needed.
  • Leading troubleshooting for operational issues, as required.
  • Assisting the supervisor with shift huddles and tier escalations, investigations, and continuous improvement projects, as needed.
  • Leading manufacturing operations tasks, as needed.
• Perform other duties, as assigned.

Basic Requirements

• Production Technician I
  • High School Diploma/GED with 1-2 years of related experience.
  • Associate’s Degree in Life Sciences with 0 years of related experience.
  • Equivalent military training/experience.
• Production Technician II
  • High School Diploma or GED with 2 years of related experience in Life Sciences Manufacturing.
  • Associate’s Degree in Life Sciences with 0 years of related experience.
  • Equivalent military training/experience.
• Production Technician III
  • High School Diploma or GED with 4 years of related experience in Life Sciences Manufacturing.
  • Associate’s Degree with 2 years of experience in Life Sciences Manufacturing.
  • BA/BS preferably in Life Sciences/Engineering with 0 years of experience.
  • Equivalent military training/experience.
• Production Technician IV
  • High School Diploma or GED with 6 years of experience in Life Sciences Manufacturing.
  • Associate degree with 4 years’ experience in Life Sciences Manufacturing.
  • BA/BS preferably in Life Sciences/Engineering with 2 years of experience in Life Sciences Manufacturing.
  • Equivalent military training/experience.
• Production Technician V
  • High School Diploma or GED with 7 years’ experience in a Life Sciences Manufacturing environment.
  • Associate Degree with 6 years’ experience in a Life Sciences Manufacturing environment.
  • BA/BS, preferably in Life Sciences/Engineering with 4 years of experience in Life Sciences Manufacturing.
  • Equivalent military experience.
• Manufacturing Lead
  • High School Diploma or GED with 8 years’ experience in a Life Sciences Manufacturing environment.
  • Associate Degree with 6 years’ experience in a Life Sciences Manufacturing environment.
  • BA/BS, preferably in Life Sciences/Engineering with 4 years of experience in Life Sciences Manufacturing.
  • Equivalent military experience.

Physical Demands:

• Ability to ascend or descend ladders, scaffolding, ramps, etc.
• Will work in environment which may necessitate respiratory protection.
• Ability to inspect or perform a task with 20/20 corrected vision, visual acuity, including distinguishing color.
• Ability to stand for prolonged periods of time up to 240 minutes.
• Ability to sit for prolonged periods of time up to 240 minutes.
• Ability to conduct activities using repetitive motions that include wrists, hands…