Validation Expert

Bayer; Toluca; Presencial; MXN 200,000 - 400,000; Jornada completa

Descripción de la vacante

A multinational healthcare company in Toluca is seeking a Validation Expert for a temporary role of 12 months. You will coordinate validation processes and ensure compliance with regulations in the pharmaceutical industry. The ideal candidate has 4 years of experience and a degree in Chemical Engineering or a related field, with strong leadership and negotiation skills. A B2 level in English is required and knowledge of statistical software is a plus.

Formación

• 4 years of experience in pharmaceutical industry.
• Knowledge of Process Validation and Critical Systems Qualification.
• English language proficiency (B2).

Responsabilidades

• Coordinate validation of processes in the Lerma Plant.
• Supervise qualification of critical systems.
• Execute qualification of pharmaceutical facilities.
• Ensure compliance with regulatory framework.
• Participate as qualification or validation leader.

Conocimientos

Leadership skills

Negotiation skills

Ability to work under pressure

Decision-making skills

Resistance to frustration

High perseverance

Flexibility

Educación

Chemical Engineer

Pharmaceutical Chemist

Biologist

Pharmaceutical Engineer

Biochemical Engineer

Herramientas

PC and statistical software

Descripción del empleo

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TASKS AND RESPONSIBILITIES

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.

Application Period

• Reference Code : Division : Consumer Health Location : Mexico : Estado de Mexico : Toluca Functional Area : Engineering & Technology Position Grade : H Employment Type : Temporary Work Work Time : Temporary

Contact Us

Address Lerma, Toluca