Senior Validation Engineer

Key Accountabilities

• Work effectively with others from diverse backgrounds and demonstrate capability to adapt to new, different, or changing requirements. Display strong moral principles and work ethics while demonstrating initiative. Maintain a professional presence and display responsible behaviors
• Knowledge and experience developing and leading CSV and Life-cycle management activities to support GxP conforming systems, facilities, manufacturing and laboratory systems
• Evaluate equipment and processes to identify critical parameters based upon potential impact on product quality attributes
• Prepare qualification, requalification, and process validation protocols, analyzes applicable data, and prepares final reports in compliance with relevant regulations, industry practices, and AZ policies and procedures
• Perform and document field verification of equipment, instruments, and facilities as required by approved protocols
• May provide supervision and training for less experienced or entry-level validation personnel, including review and enhancement of draft protocols, oversight of data collection, review/approval of raw data and assembled qualification packages
• Provide supervision and training for contract validation personnel, including review and enhancement of draft protocols, oversight of data collection, review/approval of raw data and assembled qualification packages
• Perform risk assessment on proposed changes, document change control deliverables with respect to validation requirements
• Complete, review, and/or approve risk assessments for instruments, equipment, processes, and products.
• Analyze data and information to determine whether processes, equipment, and products are within an appropriate state of control during qualification and validation as well as in assessing the need for requalification / revalidation on a periodic basis
• Prepare and/or evaluate change controls to ensure that equipment, products, processes, and facilities remain in qualified, validated state, including definition of appropriate requirements in change control documents, completion of identified action, and preparation of applicable reports and data packages
• Identify and investigate unusual or unexpected events, data, or sources of variation during the development and performance of qualifications/validations; assess and document the impact upon qualification or validation as applicable, and recommend appropriate corrective/preventive actions
• Coordinate assigned qualification projects as needed with other departments as needed
• Ensure that work is performed in accordance with applicable regulations, industry guidelines and practices, approved procedures and cGMP
• Other responsibilities as assigned by department management

Essential Requirements

• Minimum BS degree in relevant discipline
• Entry-level Master’s/ PhD degree in engineering, science, technology, or related field (OR) Bachelor’s degree with 3+ years of relevant experience.
• At least 3 years’ experience in independent development, writing and performance qualifications / validation
• Proven capability to assess processes, equipment and products for sources of variation
• Ability to analyze data and reach appropriate solutions
• Ability to perform and appropriately document deviations and investigations
• Must have excellent analytical skills and attention to detail. Work requires a high degree of accuracy in complex documentation; Able to work cooperatively and provide direction, as appropriate, to other members of the Validation Team, Engineering, Quality, and Manufacturing in the design and performance of qualification and validations.
• Must have the ability to learn technical subject matter quickly and integrate knowledge into previously known information
• Must effectively evaluation information collected from various sources and determine impact upon controlled state of processes, equipment, facilities, and products
• Must be goal oriented and quickly adaptable to new situation
• Excellent technical writing and verbal communication skills.
• Experience with Process Engineering or setting up new equipment– (URS, PID, DQ, IQ, OQ, PQ)
• Experience working with digital tools and applications related to reporting, documentation, and analysis.

Preferred Qualifications

• Ability to read P&IDs and electrical drawings
• Working knowledge of FDA guidance on Process Validation and Computer System validation
• Experience with various programming to support digital/software validation
• Knowledge of hardware and/or software integration