{"id":2575642,"url":"https://alion.io/job/astrazeneca-senior-validation-engineer","title":"Senior Validation Engineer","company":{"id":13195,"name":"AstraZeneca","domain":"astrazeneca.com","url":"https://alion.io/company/astra-zeneca","size_band":"1001-5000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":{"grade":"A","score":94,"open_postings":182,"ghost_share":0,"stale_share":0.423,"repost_share":0.049,"time_to_fill_p50_days":14,"computed_at":"2026-10-15T05:46:00Z"}},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"senior","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Redwood City, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":101643,"max":152464,"currency":"USD","period":"year","gross":null,"usd_annual":152464},"salary_estimate":null,"experience_years_min":null,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[],"status":"live","first_seen_at":"2026-10-14T00:00:00Z","employer_posted_date":"2026-10-14","last_verified_at":"2026-10-15T14:03:39Z","board_verified":true,"closed_at":null,"days_open":1,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":1},"description":"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.\nKey Accountabilities:\nWork 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\nKnowledge and experience developing and leading CSV and Life-cycle management activities to support GxP conforming systems, facilities, manufacturing and laboratory systems\nEvaluate equipment and processes to identify critical parameters based upon potential impact on product quality attributes\nPrepare 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\nPerform and document field verification of equipment, instruments, and facilities as required by approved protocols \nMay 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\nProvide 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\nPerform risk assessment on proposed changes, document change control deliverables with respect to validation requirements \nComplete, review, and/or approve risk assessments for instruments, equipment, processes, and products.\nAnalyze 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\nPrepare 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\nIdentify 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\nCoordinate assigned qualification projects as needed with other departments as needed\nEnsure that work is performed in accordance with applicable regulations, industry guidelines and practices, approved procedures and cGMP\nOther responsibilities as assigned by department management\nEssential Requirements:\nMinimum BS degree in relevant discipline\nEntry-level Master’s/ PhD degree in engineering, science, technology, or related field (OR) Bachelor’s degree with 3+ years of relevant experience.\nAt least 3 years’ experience in independent development, writing and performance qualifications / validation\nProven capability to assess processes, equipment and products for sources of variation\nAbility to analyze data and reach appropriate solutions\nAbility to perform and appropriately document deviations and investigations\nMust 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.\nMust have the ability to learn technical subject matter quickly and integrate knowledge into previously known information\nMust effectively evaluation information collected from various sources and determine impact upon controlled state of processes, equipment, facilities, and products\nMust be goal oriented and quickly adaptable to new situation\nExcellent technical writing and verbal communication skills.\nMust be goal oriented and quickly adaptable to new situation\nExcellent technical writing and verbal communication skills\nExperience with Process Engineering or setting up new equipment- (URS, PID, DQ, IQ, OQ, PQ)\nExperience working with digital tools and applications related to reporting, documentation, and analysis.\nPreferred Qualifications:\nAbility to read P&IDs and electrical drawings\nWorking knowledge of FDA guidance on Process Validation and Computer System validation\nExperience with various programming to support digital/software validation \nKnowledge of hardware and/or software integration\nThe annual base pay (or hourly rate of compensation) for this position ranges from $ 101,643.20 - $152,464.80. Our positions offer eligibility for various incentives-an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles. Benefits offered include qualified retirement programs, paid time off (i.e., vacation, holiday, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the applicable plans.\nDate Posted\n14-Oct-2026Closing Date\n05-Nov-2026Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. 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