Validation Expert
Ever feel burnt out by bureaucracy? Us too. That’s why we’re changing the way we work— for higher productivity, faster innovation, and better results. We call it Dynamic Shared Ownership (DSO). Learn more about what DSO will mean for you in your new role here https://www.bayer.com/en/strategy/strategy

TASKS AND RESPONSABILITIES

• Coordinate the Validation of the Processes of the products manufactured in the Lerma Plant, including the maintenance of the validated state (OPV: Ongoing Process Verification).
• Coordinate and supervise that the Critical Systems Qualification: Purified Water, HVAC (Pharmaceutical Air Conditioning) and Compressed Air comply with the established regulations and acceptance criteria. Execute the Qualification of the Pharmaceutical Facilities where the products are manufactured.
• Provide solution and follow-up to elements of the quality systems (Deviations, IRFES, CAPAS, Risk Analysis).
• To guarantee compliance and alignment with the national, international and corporate regulatory framework during the execution of the qualifications or validations.
• Participate in projects as qualification or validation leaders to ensure the correct implementation of pharmaceutical validation and / or qualification concepts.
• Participate in internal and external audits.

WHO YOU ARE

• Chemical Engineer, Pharmaceutical Chemist, Biologist, Pharmaceutical Engineer, Biochemical Engineer. Language: English (B2).
• Knowledge of PC and statistical software.
• Experience: 4 years of total experience in areas of the pharmaceutical industry, such as Process Validation and Critical Systems Qualification.
• The person in this position must have leadership skills, ability to negotiate, work under pressure; decision-making skills, resistance to frustration and high perseverance and flexibility.

At Bayer we believe in diversity, equity and inclusion. We aim to create an environment in which everybody can feel authentic, respected and equally valued. Every day we strive to reflect our values through our people unique capabilities, self-experiences, and aspirations. We, intentionally seek diversity, to enable our people bring their fullest potential out and encourage others to likewise do so. Our company wins, when we leverage our capabilities to lead the cultural transformation in our business, positively impacting the society.

Candidates who meet the requirements based on the job profile will be considered for employment regardless of physical disability, race, color, religion, sex, age, sexual orientation, gender identity and will not be at a disadvantage if unemployed.