Production Operations Specialist

6 days ago


Charlottetown, Prince Edward Island, Canada Next Level Group Full time

Job Summary

We are seeking a highly skilled Production Operations Specialist to join our team at Next Level Group. This role will be responsible for ensuring the smooth operation of our production processes, maintaining high-quality standards, and collaborating with cross-functional teams to achieve project goals.

About the Role

In this position, you will work in a fast-paced environment, performing various tasks such as:

  • Maintaining cell lines, completing media changes, and cell passages;
  • Operating and maintaining production instruments and equipment, including pH meters, conductivity meters, microscopes, lyophilizers, peristaltic pumps, and other production equipment;
  • Performing sterile cell culture and viral infection processes;
  • Writing and reviewing batch records, SOPs, qualification documents for viral/Renogen operations;
  • Completing timely SAP postings and maintaining department inventory;
  • Collaborating with other departments involved in GMP manufacturing for planning production, testing, and product release;
  • Working as a cross-functional team with different manufacturing groups to provide resources as needed;
  • Performing tasks under minimal supervision, and within tight timelines to meet production schedules;
  • Maintaining production equipment in good condition, as per manufacturer's specifications;
  • Maintaining the cleanliness of the production areas and following disinfection procedures of clean rooms;
  • Cleaning, preparing, and sterilizing items in autoclaves;

Requirements

To be successful in this role, you will need:

  • A minimum of 1-2 years of experience in pharmaceutical/biological manufacturing in a GMP environment;
  • A biotechnology diploma or equivalent is an asset;
  • Excellent interpersonal skills, both communication and written;
  • Outlines of Production, cGMP guidelines, and HSE regulations;
  • Experience performing investigations and writing deviations;
  • Intermediate/Expert computer skills using MS Office (Word, Excel, PowerPoint);
  • Thorough technical understanding of quality systems and regulatory requirements;

Work Environment

This role requires the ability to work shift work (12-hour daytime shifts, 3-4 days/week, including some weekends) and overtime as required. You must also be able to lift, move, and maneuver small-medium sized equipment and raw materials up to 50lbs, stand or sit for long periods, and climb ladders or stairs frequently.

Salary Information

The estimated salary for this role is $60,000 - $80,000 per year, depending on experience and qualifications.



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