AstraZeneca

1 day ago

Senior Validation Engineer

✓ Verified Job

Canonical indexed version, validated from employer's careers page.

Source: Company careers pageValidated by: Fursa AI

Last checked: 6 hours agoStatus: Live

Job Summary

Lead validation for advanced packaging and combination product assembly at the Dublin College Park site, acting as the validation subject-matter expert. Define and execute a risk-based verification strategy to qualify new lines, technologies, and process improvements. Own validation documentation, drive FAT/SAT vendor execution, and ensure audit readiness. Partner with Quality, Operations, Automation, Device Design, and Engineering while using statistical tools and digital validation platforms to improve process capability and reduce rework.

Location: Dublin

Workplace: Onsite

Employment Type: Full time

Job Function: Solutions Engineering & Sales Engineering

Seniority: Mid level

Key Responsibilities

•Define and apply a risk-based verification (RBV) approach to determine validation requirements for new equipment, products, and improvements.
•Draft, review, approve, and execute validation deliverables including test plans, risk assessments (FMEAs), protocols, data integrity assessments, and validation summary reports.
•Lead validation workstreams for major capital projects and new product introductions, ensuring on-time, compliant start-up of packaging and assembly operations.
•Lead vendor execution for FAT and SAT and drive issue resolution at source, providing progress updates to internal stakeholders.
•Serve as validation SME for regulatory audits and use statistical/digital validation tools to analyze results, identify root causes, and implement corrective actions.

Key Requirements

•Bachelor's degree (or higher) in Engineering/Life Sciences preferred.
•4-7 years of experience in validation/qualification of packaging systems or combination products in the pharmaceutical/medical device industry.
•Experience with risk-based validation and defining validation requirements for new equipment, products, and improvements.
•Proficiency in statistical tools (e.g., Minitab) and risk management methodologies (FMEA, ISO 14971), including Process Validation knowledge.
•Experience using digital validation tools (e.g., Kneat) and working knowledge of regulatory requirements/standards.

Experience:4-7 yearsPharmaceuticalMedical deviceCombination productsPackaging systemsQualificationValidation

Education:Bachelor's in Engineering/Life Sciences

Skills:LeadershipCommunicationProblem-solvingIndependent workCross-functional collaboration

Certifications:Lean Six Sigma

Tech Stack:MinitabFMEAISO 14971KneatIQ/OQ/PQURS developmentISO 1348521 CFR Part 421 CFR 820EU MDRALCOA+MESSCADAPLCFATSAT

Company Brief

AstraZeneca

Global biopharmaceutical company discovering, developing and commercializing prescription medicines across oncology, cardiovascular, renal & metabolism, respiratory, and immunology, focused on innovative therapies and vaccines to improve patient outcomes worldwide.

Industry: Pharmaceuticals

Company Size: Enterprise (1,001+ employees)

Revenue: USD 1B+

Growth: Public Company

Valuation: Public Company (Market Cap in USD)

Funding: IPO / Publicly Listed

Headquarters: Cambridge, United Kingdom

Founded: 1999

Glassdoor: 3.8

Website LinkedIn

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AstraZeneca

1 day ago

Senior Validation Engineer

✓ Verified Job

Canonical indexed version, validated from employer's careers page.

Source: Company careers pageValidated by: Fursa AI

Last checked: 6 hours agoStatus: Live

Job Summary

Location: Dublin

Workplace: Onsite

Employment Type: Full time

Job Function: Solutions Engineering & Sales Engineering

Seniority: Mid level

Key Responsibilities

•Define and apply a risk-based verification (RBV) approach to determine validation requirements for new equipment, products, and improvements.
•Draft, review, approve, and execute validation deliverables including test plans, risk assessments (FMEAs), protocols, data integrity assessments, and validation summary reports.
•Lead validation workstreams for major capital projects and new product introductions, ensuring on-time, compliant start-up of packaging and assembly operations.
•Lead vendor execution for FAT and SAT and drive issue resolution at source, providing progress updates to internal stakeholders.
•Serve as validation SME for regulatory audits and use statistical/digital validation tools to analyze results, identify root causes, and implement corrective actions.

Key Requirements

•Bachelor's degree (or higher) in Engineering/Life Sciences preferred.
•4-7 years of experience in validation/qualification of packaging systems or combination products in the pharmaceutical/medical device industry.
•Experience with risk-based validation and defining validation requirements for new equipment, products, and improvements.
•Proficiency in statistical tools (e.g., Minitab) and risk management methodologies (FMEA, ISO 14971), including Process Validation knowledge.
•Experience using digital validation tools (e.g., Kneat) and working knowledge of regulatory requirements/standards.

Experience:4-7 yearsPharmaceuticalMedical deviceCombination productsPackaging systemsQualificationValidation

Education:Bachelor's in Engineering/Life Sciences

Skills:LeadershipCommunicationProblem-solvingIndependent workCross-functional collaboration

Certifications:Lean Six Sigma

Tech Stack:MinitabFMEAISO 14971KneatIQ/OQ/PQURS developmentISO 1348521 CFR Part 421 CFR 820EU MDRALCOA+MESSCADAPLCFATSAT

Company Brief

AstraZeneca

Industry: Pharmaceuticals

Company Size: Enterprise (1,001+ employees)

Revenue: USD 1B+

Growth: Public Company

Valuation: Public Company (Market Cap in USD)

Funding: IPO / Publicly Listed

Headquarters: Cambridge, United Kingdom

Founded: 1999

Glassdoor: 3.8

Website LinkedIn