Manufacturing Associate

redShift•Stockbridge, MA

11h•Onsite

About The Position

Our growing client is seeking Manufacturing Associates (Level I & II) to support production operations across multiple shifts. This role is responsible for executing manufacturing processes, operating equipment, and ensuring compliance with strict quality and regulatory standards. This is a hands-on opportunity for individuals interested in working in a GMP-regulated environment, with exposure to advanced production systems, cleanroom operations, and continuous process improvement.

Requirements

Manufacturing Associate I: 0–2 years of experience in a manufacturing or GMP environment preferred
Manufacturing Associate II: 3–4 years of experience in a GMP or regulated manufacturing environment preferred
Associate or Bachelor's degree in a science-related field or equivalent experience (for MA I)
Bachelor's degree in a science-related field or equivalent experience (for MA II)
Basic understanding of FDA cGMP regulations
Strong attention to detail and ability to follow detailed instructions
Good written and verbal communication skills
Basic computer skills (Word, PowerPoint, etc.)
Ability to accurately complete documentation
Ability to work independently and as part of a team
Ability to work in a 24/7 shift-based environment, including nights, weekends, and off-hours
Ability to stand or sit for extended periods
Ability to lift and carry up to 50 pounds
Ability to work in cleanroom environments while wearing required PPE
Adequate visual and auditory acuity for monitoring processes and equipment

Responsibilities

Perform manufacturing activities in assigned areas following SOPs, batch records, and GMP standards
Support routine production, start-ups, changeovers, and technology transfer activities
Prepare buffers, media, and other solutions according to detailed procedures
Operate a variety of manufacturing equipment including tanks, filtration systems, CIP/SIP skids, agitators, autoclaves, glass washers, and testing devices
Work with manual, semi-automated, and fully automated aseptic filling lines
Monitor equipment performance and report issues as needed
Perform aseptic operations in controlled cleanroom environments
Follow strict contamination control procedures and gowning requirements
Complete all required documentation accurately and in compliance with cGMP standards
Maintain logbooks, batch records, and production documentation
Ensure work areas remain audit-ready at all times
Comply with FDA, OSHA, and other regulatory requirements
Work closely with team members to complete process steps safely and efficiently
Communicate any issues, deviations, or process changes to supervisors
Adapt to changing production schedules and priorities
Provide feedback and suggestions for process improvements
Complete all required training and maintain up-to-date training records
Follow established procedures and continuously develop technical skills