Quality Project Engineer

Beiersdorf; Silao (Ciudad); Presencial; MXN 200,000 - 400,000; Jornada completa

Descripción de la vacante

A leading global company in skin and body care is seeking an experienced Quality Validation Specialist for their plant in Silao, Guanajuato, Mexico. The candidate will evaluate and validate change controls and ensure compliance with GMP and international regulations while managing quality documentation. A minimum of 4 years in validation within the cosmetic or pharmaceutical industries and a Bachelor's degree in related fields are required. Advanced English skills are essential. Join a diverse team committed to innovation and responsibility.

Servicios

Inclusive company culture

Diversity and equal opportunities

Formación

• Minimum of 4 years of experience in validation and quality projects
• Proven track record with pharmaceutical or cosmetic industry equipment
• Advanced English proficiency required

Responsabilidades

• Evaluate and approve URS, commissioning, and validation activities
• Ensure compliance with qualification protocols and GMP standards
• Manage project documentation for Quality Management System

Conocimientos

Validation and quality project experience

Knowledge of manufacturing and filling equipment

Experience with Quality Management Systems

Educación

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

Herramientas

GMP standards

ISO standards

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.