Quality Project Engineer

Beiersdorf AG; Silao (Ciudad); Presencial; MXN 720,000 - 1,081,000; Jornada completa

Descripción de la vacante

A global skincare company in Silao, Mexico, is seeking a Validation and Quality Manager. This role involves ensuring compliance with GMP and overseeing change controls within projects at a regulated manufacturing plant. Ideal candidates have over 4 years of experience in the pharmaceutical industry, a Bachelor’s degree in a relevant field, and knowledge of quality management systems. The company values inclusivity and responsibility, and offers an enriching working environment.

Formación

• Minimum of 4 years of experience in validation and quality projects within the cosmetic/pharmaceutical industry.
• Experience with manufacturing and filling equipment for liquid and semi-solid products.
• Experience with regulations: COFEPRIS, FDA, Health Canada.

Responsabilidades

• Evaluate and approve URS, FAT/SAT protocols, and validation activities for equipment.
• Prepare and review compliance of qualification protocols in accordance with GMP.
• Manage project documentation related to the Quality Management System.
• Participate in internal and external quality audits.

Conocimientos

Validation and quality projects experience

Knowledge of equipment lifecycle

Quality Management Systems experience

Advance English

Educación

Bachelor’s degree in Pharmaceutical Chemistry, Chemical Engineering, Biochemistry, Biotechnology, or related field

Descripción del empleo

Your Tasks

Ensure the proper planning, documentation, evaluation, and execution of change control, design review, commissioning, qualification, and validation processes for equipment, facilities, computerized systems, and critical systems within projects at a regulated manufacturing plant (OTC and cosmetics), ensuring compliance with applicable national and international regulations and the Quality Management System.

Key Responsibilities

• Evaluate and approve URS, FAT/SAT protocols, commissioning, and qualification/validation activities for equipment, facilities, and critical systems.

• Prepare, review, and ensure compliance of qualification and validation protocols in accordance with GMP and international standards (ISO, GAMP 5, CFR 21 Part 11, WHO, among others).

• Manage and maintain project documentation related to the Quality Management System.

• Manage and follow up on change controls, ensuring GMP compliance.

• Participate in internal and external quality audits, providing technical support and responses.

• Coordinate and participate in quality risk assessments for assigned projects.

• Update and/or develop procedures aligned with applicable regulations and plant requirements.

• Ensure compliance with environmental, health, and safety policies.

• If applicable, manage direct reports by conducting performance evaluations, providing feedback, setting objectives, monitoring KPIs, and following up on annual training plans.

Your Profile

• Minimum of 4 years of experience in validation and quality projects within the cosmetic and/or pharmaceutical industry.

• Experience with manufacturing and filling equipment for liquid and semi-solid products.

• Knowledge of the lifecycle of equipment, facilities, and critical systems.

• Experience with Quality Management Systems (GxP, CAPA, deviations, change control).

• Education: Bachelor’s degree in Pharmaceutical Chemistry (QFB/QFI), Chemical Engineering, Biochemistry, Biotechnology, or related field.
• English : Advance

Technical Knowledge

• Good Documentation Practices (GDP).

• Regulations: COFEPRIS, FDA, Health Canada.

• Guidelines and standards: GAMP 5, ISO 14644, ISO 8573, ICH, ISPE, WHO.

• Quality risk assessment and project management.

Competencies

• Integrity

• Decision-making

• Strategic vision

• Leadership

At Beiersdorf, we want to help people feel good about their skin – and our commitment goes far beyond caring for skin. For 140 years, we have developed innovative skin and body care products for well-known brands such as NIVEA, Eucerin, La Prairie, Hansaplast, and Labello. We act according to our purpose, WE CARE BEYOND SKIN, and take responsibility for our consumers, our employees, the environment and society.

Behind every brand, every product and every accomplishment are our more than 20,000 employees. It is for them that we live an inclusive culture of respect and trust that is strongly aligned with our values – CARE, COURAGE, SIMPLICITY and TRUST. We also embrace diversity by valuing the uniqueness of each individual and being committed to equal opportunities for all.