- 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 and disinfects doors, floors, walls, ceilings and filling equipment using aseptic technique with the correct chemicals, and cleaning equipment in critical and control areas following all applicable SOP.
- Conducts the disassembly, product removal, changeover, functionality testing and cleaning and disinfection of fillers. Washes, reassembles and wraps equipment for autoclave loads.
- Works closely with the batching staff to conduct Clean Room activities associated with CIP, SIP and product filtration.
- Test runs equipment to ensure changeover of filling lines is correct and operational.
- Loads and unloads dry heat sterilization oven and autoclaves.
- Transfers sterilized equipment, components and bottles to each of the filling lines.
- Conducts filtration of WFI for cleaning activities.
- Documents all activities as they occur in log books and Production dockets.
- Stocks supplies and removes garbage as required.
- Assists the Aseptic Technician level 2 with the training of new operators as required.
- Other duties as assigned
Specific Skill Requirement:
- 1-2 years in a Pharmaceutical manufacturing GMP environment
- High School Diploma or GED
- Excellent math skills. Good command of the English Language, verbal, reading and writing.
- Strong hand & eye coordination. Able to lift and move heavy objects 20 – 30kg, visual acuity, manual dexterity, some repetitive movements.
- Requires sustained motion of arms at all levels and fine finger activities including gripping, pinching and pulling.
- Must be able to work while wearing full protective gowning for entire shift.
- High integrity, excellent attention to detail, ability to organize and prioritize, and work in team environment, take initiative
At Bimeda we are committed to fostering an inclusive, barrier-free and accessible environment. Part of this commitment includes arranging accommodations to ensure an equitable opportunity to participate in the recruitment and selection process. If you require an accommodation, we will work with you to meet your needs. The job posting is available in an accessible format upon request by contacting the Human Resources Manager.
Please note that this job description is not exhaustive, and the role holder may be required to undertake other relevant duties commensurate with the grading of the post. Activities may be subject to amendment over time as the role develops and/or priorities and requirements evolve.
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 optimise the health, wellbeing and productivity of the world’s animals.
Bimeda’s global innovation programme sees six state-of-the art R&D centres 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 commercialisation 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