
Validation Engineer
hace 2 semanas
BioPharma Consulting JAD Group is looking for a skilled Validation Engineer to play a pivotal role in our operations.
This crucial position involves overseeing the validation processes for our pharmaceutical and biopharmaceutical products, ensuring compliance with industry regulations and standards.
Key Responsibilities: Lead, execute, document, and manage commissioning and validation activities (SAT/FAT/IC/OC/IQ/OQ/PQ) for Manufacturing Equipment, Utilities and Facilites using Kneat.
Develop design documents such as Traceability Matrices, User Requirements, Impact Assessments, and Design Qualifications associated to the systems within the scope of the project using the Kneat platform.
Availability to work on-site as needed.
Promote cooperation and teamwork across all departments through open, candid communication and timely coordination.
Additional Responsibilities: Maintain and improve the validation process and documentation practices.
Provide training to staff on validation practices and regulatory compliance.
Reporting of key validation metrics to management for review and continuous improvement.
Skills GMP and Validation document writing (Design Documents and C&Q Documents) Experience with Kneat Paperless Validation software (preferred-not a must) Work in team environment Able to coordinate with other departments and good communication skills Technical Writing Requirements Qualifications: Bachelor's degree in Engineering, Life Sciences, or a related field.
5+ years of experience in validation within the pharmaceutical or biotechnology industries.
Strong knowledge of cGMP, GLP, and GxP regulations.
Demonstrated experience in writing and executing validation protocols.
Proficiency in technical writing and data analysis.
Excellent problem-solving skills and attention to detail.
Effective communication skills, both verbal and written.