Manufacturing Associate III

About the role

The Manufacturing Associate III executes processing steps and associated activities while maintaining strict adherence to Current Good Manufacturing Practice (CGMP), quality and regulatory standards. Flexibility with working hours and shift rotation is essential to effectively support the 24/7 manufacturing facility.

Responsibilities

• Executes and documents manufacturing processing steps or support activities, process monitoring, and control within at least one functional area in manufacturing (e.g., Fermentation, Purification, Recovery, Cell Culture) and all support functions (e.g., Glasswash, Buffer/Solution Prep)
• Performs in-process sampling and testing (e.g., pH, conductivity, visual inspection)
• Executes validation protocols according to CGMP standard operating procedures (SOPs)
• Maintains training to perform all required activities
• Performs manufacturing task execution using all applicable areas of Distributed Control Systems (DCS) (Delta V, 800xA, Unicorn, etc.)
• Cleans equipment using CIP, SIP and other methods
• Conducts takeouts, identity check returns and other tasks in Manufacturing Execution System (MES)
• Performs other duties, as assigned

Requirements

• High School Diploma/GED with 4+ years of related experience in a cGMP manufacturing environment; or Associate’s degree in life science, engineering, or relevant technical field with 2+ years of experience in a cGMP manufacturing environment; or Bachelor's degree in life science, engineering, or relevant technical field with no prior experience; or Equivalent Military training or experience
• Experience with unit operation (e.g., Cell Culture, Fermentation, etc.)
• BioWork Certificate

Qualifications

• Effective communication, both written and verbal
• Knowledge of CGMP, safety, and operational procedures
• Ability to work in a team environment
• Time management skills and detail oriented
• Must be able to support 24/7 manufacturing facility working shift (2-2-3 days/nights)

Skills

• Knowledgeable in Distributed Control Systems (DCS) (Delta V, 800xA, Unicorn, etc.)
• Proficient in Manufacturing Execution System (MES)
• Ability to work in warm/cold environments (0-100F)

Benefits

Company benefits vary based on location and position. For details, please refer to the company website or contact HR.

Pay

Compensation is competitive and commensurate with experience. Details can be found on the company website or during the interview process.

Schedule

Shift work is required, with a 2-2-3 day/night rotation.

Physical Demands

• Will work in an environment which may necessitate respiratory protection
• Ability to discern audible cues
• Ability to inspect or perform a task with 20/20 corrected vision, visual acuity, including distinguishing color
• Ability to ascend or descend ladders, scaffolding, ramps, etc.
• 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 and/or fingers
• Ability to conduct work that includes moving objects up to 33 pounds
• Ability to bend, push or pull, reach to retrieve materials from 18” to 60” in height, and use twisting motions
• Will work in warm/cold environments (0-100F)

Major Accountabilities

Executes and documents manufacturing processing steps or support activities, process monitoring, and control within at least one functional area in manufacturing (e.g., Fermentation, Purification, Recovery, Cell Culture) and all support functions (e.g., Glasswash, Buffer/Solution Prep)

Performs in-process sampling and testing (e.g., pH, conductivity, visual inspection)

Executes validation protocols according to CGMP standard operating procedures (SOPs)

Maintains training to perform all required activities

Performs manufacturing task execution using all applicable areas of Distributed Control Systems (DCS) (Delta V, 800xA, Unicorn, etc.)

Cleans equipment using CIP, SIP and other methods

Conducts takeouts, identity check returns and other tasks in Manufacturing Execution System (MES)

Performs other duties, as assigned