Senior Quality Validation Engineer - Katalyst Healthcares & Life Sciences

• Plans, implements a robust cleaning and sanitization program by authoring and leading the sanitization Validation Program for all products and product contact equipment.
• Leads the execution of the cleaning and sanitization validations by authoring protocols, hands on execution of the protocols and authoring the final report
• Ensures that deliverables are carried out in a timely and compliant manner.
• Author or update SOP's to support the cleaning the sanitization program.
• Lead the training for the processing and packaging personal on the execution of the cleaning and sanitation SOP's
• Supports the Sr. Quality Manager during external and regulatory audits.
• Leads the activities related to investigations for Micro OOS's, initiates and follows-up on the implementation of corrective actions
• Subject Matter Expert in the field of Cleaning and sensitization program & Validations
• Leads the personal Hygiene program to ensure proper PPE's for the site are appropriate for each area of the facility and ensuring cGMP's are followed and adhered to.
• Support the Cleaning & Sanitization processing and packaging personal
• Reviews performances of Cleaning and Sanitization program in regard to the achievement of goals, objectives and key result areas.
• Designs, develops and evaluates plans for projects/studies/investigations/reviews.
• Completely responsible for planning and execution of all tasks needed to the execution of the cleaning validations.
• Seeks advice on planning from management when there are priority conflicts.
• Able to make independent contributions to the development of new technologies, developing and revising methods and procedures to assure compliance with applicable regulations; carries out technical and administrative duties as assigned.
• Trains on new and existing procedures, techniques and governmental regulations as directed by management.

Requirements:

• BS degree in Biology, Chemistry, Microbiology, Biochemistry or relevant science discipline 8 years of relevant Quality experience preferably in the pharmaceutical industry.
• MS degree in Biology, Chemistry, Microbiology, Biochemistry or relevant science discipline 6 years of relevant Quality experience preferably in the /pharmaceutical industry.
• Strong background in Cleaning and sanitization program and validations
• Mentor/trains in routine procedures demonstrating expertise.
• Extensive practical and solid theoretical knowledge of applicable compliance guidelines of the FDA or other regulatory bodies; and relevant Fareva SOPs.
• In addition to high technical competence, understands and can articulate the scientific/regulatory principles that underlie practices and guide future projects/studies/reviews development. Continues to expand breadth of technical expertise.
• Ability to interpret and document results according to standard operating procedures using all Quality Systems guidelines.
• Demonstrated ability to independently develop, document and troubleshoot methods of moderate complexity.
• Ability to lead teams from work cross functional areas
• Ability to provide equipment and procedure training and to share technical expertise with less experienced colleagues to solve problems.
• Can independently design and carry out a series of studies/reviews to solve a problem or evaluate a process/procedure. Solutions may involve the development of new techniques and procedures. Uses literature and colleagues as resources to solve problems.