Production Operations Specialist

1 week ago


Lee, Massachusetts, United States BERKSHIRE STERILE MANUFACTURING LLC Full time
Job Overview

We are seeking a highly skilled Production Operations Specialist to join our team at Berkshire Sterile Manufacturing LLC.

This role is perfect for individuals with experience in GMP environments and a strong understanding of manufacturing processes.

About the Role

The successful candidate will be responsible for operating production equipment, preparing solutions, and performing aseptic operations in clean room environments.

You will also be required to adhere to scheduling changes, communicate with supervisors, and participate in presenting manufacturing areas in an audit-ready state.

Key Responsibilities
  • Operate process equipment, including tanks, CIP/SIP skids, agitators, filtration devices, autoclaves, glass washers, integrity testing, and small equipment
  • Perform manual, semi-automatic, and fully automatic isolated-based aseptic filling line operations
  • Prepare buffers, media, and solutions following written procedures and batch records
  • Perform process steps in coordination with other associates, requesting help as needed
  • Adhere to scheduling changes and respond appropriately
  • Communicate with supervisors regarding work orders or shifts in process parameters
  • Provide input and suggestions to improve processes
  • Follow all GMPs and EHS procedures
  • Attend and complete assigned training
  • Ensure training plans are accurate and up-to-date
  • Complete necessary documentation per GMP practices
  • Participate in presenting manufacturing areas in an audit-ready state
Regulatory Responsibilities
  • Conduct business in a responsible manner, complying with state, FDA, OSHA, and HIPAA regulations
Supervisory Responsibilities
  • No supervisory responsibilities
Requirements
  • Manufacturing Associate I: Zero to two years' experience in a GMP environment and approved laboratory under minimal supervision preferred
  • Manufacturing Associate II: Three to four years' experience in a GMP environment and approved laboratory under minimal supervision preferred
Education
  • Manufacturing Associate I: Associates or Bachelor's Degree in a science-related discipline or equivalent GMP experience
  • Manufacturing Associate II: Bachelor's Degree in a science-related discipline or equivalent GMP experience
  • Degree in another discipline (or lack thereof) may be considered if sufficient technical depth has been achieved from professional experience
Knowledge, Skills & Abilities
  • Understanding of basic FDA cGMP regulations
  • Verbal and written skills
  • Basic software application skills (Word, PowerPoint)
  • Able to follow detailed processing instructions
  • Accurately document all necessary documentation
  • Satisfactory audio-visual acuity
  • Ability to read and write English
  • Familiarization with technical issues in the area
  • Ability to work shift that covers 24/7 operation
Salary and Benefits

$60,000 - $80,000 per year, depending on experience

Benefits include health insurance, retirement plan, paid time off, and opportunities for career growth and development



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