Production Operations Specialist
6 days ago
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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