Sterile Batcher (Afternoon) Monday-Friday, 3:00pm - 11:30pm

Bimeda•Cambridge, ON

1d•CA$30 - CA$31•Onsite

About The Position

Reporting to the Production Supervisor, the Sterile Batching Operator manufactures quality pharmaceutical products by following all relevant Standard Operating Procedures (SOP), Master Batch Records (MBR), and Health and Safety requirements in compliance with cGMP.

Requirements

High School Diploma required
Excellent math skills to perform calculations using simple mathematical formulas using fractions, percentages and significant numbers.
Good command of the English language. Must be able to read, understand, follow and comply with technical and written documents and processing instructions as well as clearly and accurately document all required information into batch documents.
Mechanical aptitude required in order to operate pumps, scales, PLC’s and PH meters
Must be able to work around chemicals such as acids, bases, oxidizers and cleaning solvents while wearing appropriate PPE.
Physical requirements include stooping, bending, standing, climbing and lifting of between 20 kg – 30kg.
Must be able to work while wearing full protective gowning for entire shift.
High integrity, flexibility in working overtime, responsible, reliable, with good attention to details, good problem-solving skills
Ability to work effectively independently and part of a team

Nice To Haves

2 – 4 years experience sterile batching in a GMP pharmaceutical packaging & manufacturing facility preferred
College Diploma in Sciences or BSc an asset

Responsibilities

Works in compliance with established Standard Operating Procedures (SOPs), Good Manufacturing Practices (GMP) and safety policies.
Completes all required GMP documentation in an accurate and timely manner according to Bimeda’s Good Documentation SOP and procedures and maintains data integrity. Initials and dates any errors.
Wears required personal protective equipment and follows aseptic procedures when gowning, de-gowning and working in the sterile and controlled areas.
Reports any accidents, incidents and injuries or illnesses immediately and notifies Supervisor of any hazards, unsafe acts or conditions in the workplace.
Prepares for production run by reviewing the production schedule; identifying batch specific requirements; weighing and measuring ingredients and compounding them as per production docket and SOP.
Completes all necessary cleaning and preventative maintenance checks on equipment before production.
Operates and monitors batching equipment; observing and recording varying conditions; adjusting equipment and controls; conducting dilutions and yield calculations and following all relevant procedures.
Troubleshoots breakdowns and works closely with maintenance to resolve issues.
Documents all activities as they occur in log books and Production dockets as required. Maintains cleaning logs per SOP requirements
Updates job knowledge by participating in training opportunities. Takes ownership for individual training plan.
Assists with the training of new operators as required.
Other duties as assigned