Position Summary: Develop and execute qualification and validation processes for equipment, systems, and processes in the pharmaceutical/chemical-pharmaceutical/medical device industry, ensuring regulatory compliance and product quality. Key Highlights: 1. Key role in equipment and process qualification and validation. 2. Ensures regulatory compliance and product quality. 3. Management of technical documentation and validation programs. **Required:** Chemist/Pharmacist/Industrial Chemist/Chemical Engineer or related degree **Experience:** 1 year in a similar position within pharmaceutical/chemical-pharmaceutical/medical device companies **Position Objective:** Develop and execute qualification and validation processes for equipment, systems, and processes, ensuring compliance with current regulations and product quality; develop and update procedures applicable to the area, ensuring control and tracking of the Qualification/Validation Program. **Technical Knowledge:** * Draft, update, and review qualification, validation, and qualified/validated status maintenance protocols and reports in accordance with the Validation Master Plan guidelines * Coordinate all activities related to the documentation system, including development of qualification and validation protocols and reports. * Review and approve technical documentation related to qualifications/validation * Coordinate qualification/validation activities with other departments * Execute qualified/validated status maintenance processes for equipment, systems, and processes according to the Validation Master Plan and established schedule * Ability to draft clear and precise technical documentation * Analytical and problem-solving capability; knowledge of Good Manufacturing Practices (GMP) * Knowledge of Good Documentation Practices (GDP) * Knowledge of NOM-164-SSA-2015 Good Manufacturing Practices for Pharmaceutical Products. **Responsibilities:** \- Integrate documentation for the Validation area \- Develop Standard Operating Procedures (SOPs) for developing the VMP, protocols, reports, and addenda for qualification/validation processes \- Prepare process validation reports \- Prepare and report on cleaning process validation, equipment qualification, facility qualification, and critical system qualification \- Coordinate and execute, together with various plant departments, facility qualification, critical system qualification, equipment qualification, cleaning validation, and analytical method validation \- Monitor the Qualification/Validation Program \- Verify compliance with current health regulations and safety procedures \- Participate in risk analysis for processes and products per departmental procedures \- Ensure fulfillment of qualification and validation prerequisites as specified in protocols \- Prepare qualification and validation reports, maintaining traceability of activities. **Competencies:** \- Data analysis \- Problem solving \- Risk management and assessment techniques \- Multi-project management **Schedule:** Monday to Friday Statutory benefits. Employment type: Full-time Salary: $9,480.00 \- $11,000.00 per month Work location: On-site employment