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Full-time
Career opportunities, Flexibility
Posted 7d ago
~40 hrs/week
Responsibilities
Lead the lifecycle validation activities for computerized systems, including automated production equipment and facility management systems. Ensure all systems comply with GxP, GAMP5, and FDA regulations while supporting internal and external audits.
Requirements
Requires 5-7+ years of dedicated CSV experience in pharmaceutical, biotech, or medical device manufacturing. Candidates must possess professional fluency in both Norwegian and English.
Full job description
Job Description Summary
This role is ideal for an experienced Computerized Systems Validation (CSV) professional with 5–7+ years of experience in regulated pharmaceutical, biotech, or medical device manufacturing. The position focuses on validating and maintaining compliant computerized systems, ensuring data integrity and regulatory compliance, while collaborating with Automation, IT, and Quality teams to support audits and system lifecycle management.
tex
Job Description
Key Responsibilities
Validation Lifecycle Management
Lead the lifecycle validation activities for computerized systems, including automated production equipment, DBR, DCS, BMS, and FMS.
Compile, review, and execute validation blueprints, including User Requirement Specifications (URS), Functional Specifications (FS), Risk Assessments, and Validation Plans.
Protocol Execution & Testing
Author and execute Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols.
Document test deviations, perform thorough root-cause analysis, and manage Corrective and Preventive Actions (CAPAs) through to closure.
Regulatory Compliance & Data Integrity
Ensure all computerized systems strictly comply with GxP, GAMP5, Annex 11, and FDA 21 CFR Part 11 regulations.
Conduct ALCOA+ data integrity assessments on PLCs, HMIs, and environmental monitoring databases to ensure secure data tracking.
Audit Readiness & Maintenance
Maintain computerized systems in a continuous state of control and audit readiness.
Support internal and external regulatory inspections (such as NoMA/Statens legemiddelverk or FDA) as the subject matter expert for CSV.
Cross-Functional Collaboration
Partner closely with automation engineers, IT, and Quality Assurance to execute system changes via formal Change Control procedures.
Bridge technical communication gaps by explaining complex validation strategies fluently in both Norwegian and English.
Technical Requirements
CSV Expertise: Strong proficiency in GAMP5 methodologies and validating automated manufacturing and facility systems.
System Familiarity: Hands-on validation experience with Siemens/Rockwell PLC/HMI platforms, Honeywell EBI BMS, and validated environmental monitoring software (FMS).
Industry Experience: Minimum of 5-7 years of dedicated CSV experience within a validated pharmaceutical, biotech, or medical device manufacturing plant.
Quality Systems: Direct experience using formal Change Control, Deviation Management, and Risk Management frameworks.
Language & Soft Skills
Norwegian: Native or professional fluency (B2/C1 minimum) required for local regulatory compliance documentation and team collaboration.
English: Professional working proficiency required for corporate reporting, global policy alignment, and international audits.
Attention to Detail: Exceptional documentation skills with a commitment to maintaining precise, compliant records under tight timelines.
GE HealthCare is a leading global medical technology and digital solutions innovator. Our purpose is to create a world where healthcare has no limits. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world.
GE HealthCare is an Equal Opportunity Employer where inclusion matters. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.
We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership – always with unyielding integrity.
Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you’d expect from an organization with global strength and scale, and you’ll be surrounded by career opportunities in a culture that fosters care, collaboration and support.
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Related keywords
Computer System ValidationCSVPharmaceuticalBiotechMedical DeviceManufacturingData IntegrityGxPGAMP5Annex 11FDA 21 CFR Part 11ALCOA+PLCHMIHoneywell EBIBMS
Every day millions of people feel the impact of our intelligent devices, advanced analytics and artificial intelligence. As a leading global medical technology and digital solutions innovator, GE HealthCare enables clinicians to make faster, more informed decisions through intelligent devices, data analytics, applications and services, supported by its Edison intelligence platform.
With over 100 years of healthcare industry experience and around 50,000 employees globally, the company operates at the center of an ecosystem working toward precision health, digitizing healthcare, helping drive productivity and improve outcomes for patients, providers, health systems and researchers around the world.
We embrace a culture of respect, transparency, integrity and diversity and we work to create a world where healthcare has no limits.
Every day millions of people feel the impact of our intelligent devices, advanced analytics and artificial intelligence. As a leading global medical technology and digital solutions innovator, GE HealthCare enables clinicians to make faster, more informed decisions through intelligent devices, data analytics, applications and services, supported by its Edison intelligence platform.
With over 100 years of healthcare industry experience and around 50,000 employees globally, the company operates at the center of an ecosystem working toward precision health, digitizing healthcare, helping drive productivity and improve outcomes for patients, providers, health systems and researchers around the world.
We embrace a culture of respect, transparency, integrity and diversity and we work to create a world where healthcare has no limits.