Technician, Operations /Technicien(ne) des opérations

MSD•Charlottetown, PE

3d•CA$50,160 - CA$75,240•Onsite

About The Position

To produce veterinary biologics according to a defined production schedule following cGMP guidelines and specific Outlines of Production to meet market demands for aquaculture products.

Requirements

High School Diploma
1-3 years of experience in production preferred.
1-3 years of experience in aseptic techniques or cell culture experience is considered an asset.
Excellent interpersonal skills, both communications and written.
Intermediate/Expert computer skills using MS Office (Word, Excel, Power Point).
Thorough technical understanding of quality systems and regulatory requirements.
Must be able to work 8-hour daytime shifts, Monday to Friday (including some weekends and overtime as required).
Required to assist in disinfection procedures involving hazardous chemicals requiring the use of a respirator.
Must be able to lift, move and maneuver small-medium sized equipment and raw materials up to 50lbs.
Requires the ability to stand or sit for long periods of time.
Requires frequent ladder or stair climbing.
Must be able to read, write, understand, and comply with appropriate standard operating procedures.

Responsibilities

Adhere to the principles of “safety first, quality always.”
Perform sterile manipulations in both a biosafety hood and isolator.
Maintain a cell line by completing media changes and cell passages.
Operate and maintain production instruments and equipment, such as pH meters, conductivity meters, microscopes, lyophilized, peristaltic pumps, and other production equipment.
Perform sterile cell culture and viral infection processes.
Write and review batch records, SOPs, and qualification documents for viral/Renogen operations.
Complete timely SAP postings and maintain department inventory.
Comply with safety requirements, cGMP, SOPs, and manufacturing documentation.
Collaborate with other departments involved in GMP manufacturing for planning production, testing, and product release in a timely manner, resulting in successful completion of projects.
Work as a cross-functional team member with different manufacturing groups to provide resources as needed.
Perform tasks under minimal supervision and within tight timelines to meet production schedules.
Assist in maintaining production equipment in good condition as per manufacturer’s specifications.
Maintain the cleanliness of the production areas and follow disinfection procedures for clean rooms.
Clean, prepare, and sterilize items in autoclaves.
Other duties as required.
The position requires a medical assessment in accordance with applicable GMP regulations and site requirements.