Operario-Proceso aséptico Turno

Job Title

Cooper Surgical is a leading fertility and women's healthcare company dedicated to putting time on the side of women, babies, and families at the healthcare moments that matter most in life. As a division of Cooper Companies, we're driven by a unified purpose to enable patients to experience life's beautiful moments.

• Perform aseptic liquid filtration and filling of IVF media into various size bottles and micro vials using automated filling machines or manual processes inside ISO classified clean rooms.
• Perform disinfections and cleaning of machine critical areas as part of operation start-up and, changeovers and close-down.
• Assists in transferring material to and from the cleanroom ensuring not compromising the sterile barrier of components.
• Prepares filling line sets including component washing, assembly and sterilization using dry-heat or steam sterilizer.
• Follow all safety rules, SOPs, cGMP, work rules and other company policies and initiatives.
• Assure the sampling and material identification for quality control inspections.
• Completes batch records and other documentation following GDP/GMP guidelines.
• Maintains cleanliness and order in rooms, shelves, and equipments.
• Escalate all relevant information and issues timely to lead and supervisor.
• Encourages and maintains a positive attitude of teamwork in fulfillment of the common production goal.
• Performs additional duties as requested by their superiors.

• Performance index or performance against the objectives of production volume, time and product scrap.
• Ensure that microbiological environmental and gowning monitoring results remain within the established limits for the applicable ISO classification.
• Zero safety incidents attributable to procedural non-compliance or unsafe behaviors.
• Zero quality events attributable to non-compliance with procedures or work instructions.
• On-time training.
• High presenteeism and availability for planned and non-planned overtime.
• Order and organization of the area.

• Completed Secondary Education or "Bachillerato".
• Minimum 3 years' experience in clean rooms (medical or pharmaceutical industry).
• Experience with aseptic processes, bottle filling operations, and/or similar manufacturing processes, along with a basic understanding of microbiology principles related to medical devices or the pharmaceutical industry. (Preferred)
• Ability to read, analyze, and interpret technical procedures, drawings, procedure manuals.
• Have knowledge of standard units of measurement (including metric) with the ability to calculate figures and quantities, such as proportions, percentages, volume, and weight.
• Ability to follow procedures meticulously.
• Ability to work and communicate effectively and professionally with staff in all departments.
• Ability to work for extended periods in production areas that require special clothing for cleanroom and operating procedures and/or may be slightly cooler than the normal ambient room temperature.
• Possess basic English reading skills – B1 is an advantage.

Cooper Surgical does not discriminate against any employee or applicant for employment on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, age, national origin, disability, genetic characteristic, or other characteristics protected by law. Company policy also prohibits harassment of employees or applicants based on these characteristics.

• Job Identification 11209
• Job Category Manufacturing
• Job Schedule Full time
• Job Shift Day
• Locations Coyol Free Trade Zone, La Garita, Alajuela, CR (On-site)
• Company Cooper Surgical