Job title: Aseptic Technician Level III

Location: Cambridge, ON (In-office)

Position Type: Full-time, regular

**Shift:**Day Shift , Monday-Friday, 6:00am - 2:30pm

Vacancy Status: This position is vacant

AI Disclosure in Hiring: We do not use artificial intelligence to screen, assess, or select applicants

Job Summary

Reporting to the Production Supervisor, the Aseptic Technician level 3 is responsible for the Equipment setup, troubleshooting and operation of the clean room equipment under Aseptic conditions. This includes in-process control testing according to specific product requirements and in compliance with cGMP, SOPs and Bimeda quality standards.

The Aseptic Technician Level 3 supports the Operations team on projects, validation initiatives, deviation investigations and CAPA implementation.

Compensation:$30.72/Hour. After completion of probation:$31.20/Hour

Job Duties

• Demonstrates proficiency for all responsibilities of an Aseptic Technician Level 1 and Level

• Ensures that all work is carried out in compliance with company Safety Policies, Good Manufacturing Practices (GMP) and Standard Operating Procedures (SOPs).

• Wears proper 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 manager of any hazards, unsafe acts or conditions in the workplace.

• Cleans, sanitizes and/or sterilizes all equipment and bottles used to store, transfer, fill or filter products.

• Monitors the EM system and notifies Supervisor / Microbiology of any anomalies.

• Performs in-process testing and responds to manufacturing and environmental feedback from various monitoring systems.

• Applies all required status labeling to in-process materials.

• Conducts filling operations following all required Aseptic technique.

• Documents all activities as they occur in log books, attachments and activity logs as required. Maintains cleaning logs per SOP requirements.

• Assists with the training of new operators (Aseptic technician level 1 and 2) as required.

• Other duties as assigned.

Additional Responsibilities:

• Conducts setup activities of filling and Product transfer equipment following all necessary SOP and Aseptic technique requirements ensuring a smooth operation of the lines

• Identifies and initiates investigations or change controls to identify or correct non-conformances. (Deviations, SOP updates)

• Participates in new projects as an Aseptic filling lead and SME for filling operations

Experience

• Proficiency for all responsibilities of an Aseptic Technician Level 1 & 2- Required

• 4 years in a Pharmaceutical manufacturing GMP environment

• High School Diploma required

Technical/Physical & Behavioural Abilities

• Must be able 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. Must be able to stand with very few movements in a clean room environment for up to 3 hours

• High integrity, excellent attention to detail, ability to organize and prioritize, and work in team environment, take initiative

What we offer

• Medical, Dental, Vision Benefits.

• Defined Contribution Pension Plan**(2.5% Employee / 8% Employer Contribution).**

• Employee Assistance Program.

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 eight 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.

More info at****www.bimedacareers.com

Equal Opportunity & Accessibility

At Bimeda we are committed to fostering an inclusive, barrier-free and accessible environment. Part of this commitment includes arranging accommodations to ensure as equitable opportunity to participate in the recruitment and selection process. If you require an accommodation, we will work with you to meet your needs. We are committed to an inclusive and accessible recruitment process. We are an equal opportunity employer and assess candidates based on skills and experience. Recruitment records are retained in accordance with Ontario Law.