Job Description

Job Summary
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.
Shift: Monday - Friday, 11:00PM - 7:30AM
Compensation: $29.29/Hour. After completion of probation: $29.81/Hour
Job Duties

• 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

Technical/Physical & Behavioural Abilities

• 2 - 4 years experience sterile batching in a GMP pharmaceutical packaging & manufacturing facility preferred

• High School Diploma required
• College Diploma in Sciences or BSc an asset
• 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

About Bimeda
Bimeda is a leading global innovator, manufacturer and marketer of veterinary pharmaceuticals and animal health products and has over half a century's experience in providing science-driven solutions to optimize the health, wellbeing and productivity of the world's animals.
Bimeda's global innovation program sees six state-of-the art R&D centers across four continents collaborate on an enviable product development pipeline which anticipates the ever-evolving needs of the animal health industry.
Bimeda's nine manufacturing facilities across seven countries allow the company to manufacture a broad range of preventative, curative and nutritional products including sterile injectables, vaccinations, nutritional boluses, feed additives, tablets, water-soluble powders, pastes and non-sterile liquids.
Globally, the company focuses on the development, manufacture and commercialization of quality Bimeda-branded products while also being the partner of choice for contract manufacturing and R&D services for prominent companies within the animal health industry.
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