Senior Validation Engineer

AstraZeneca•Redwood City, CA

About The Position

Role is heavily focused to support the key site digital/software/automation transformation and related validation activities. The first two years will focus on validation of digital tools (MES systems, software, etc) and may require continued administrative support of this system. Responsible to perform adequate and comprehensive qualification and validation of equipment, processes, products, and facilities at the Redwood City site to support the site goals and targets. Responsible for assuring the design, installation, implementation, data integrity and validation of computer systems meet all applicable industry standards and regulatory requirements to support the site goals and targets. System or business owner and oversee the system from implementation ensuring proper documentation at every phase. 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 Support implementation of the Site Digital Technology Strategy and roadmap: architect key strategic digital transformation initiatives aligned to business priorities and value targets. 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 Assess accuracy of P&ID, Electrical drawing to support validation and change control 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

Requirements

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
Experience in and knowledge of qualification of control systems and computer system validation
Proven capability to assess processes, equipment and products for sources of variation
Ability to analyse 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.
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.

Nice To Haves

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

Responsibilities

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 Support implementation of the Site Digital Technology Strategy and roadmap: architect key strategic digital transformation initiatives aligned to business priorities and value targets.
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
Assess accuracy of P&ID, Electrical drawing to support validation and change control
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