Validation Engineer

What we expect of you

We are all different, yet we all use our unique contributions to serve patients.

• Basic Qualifications and Experience :
• Master s degree and 2 to 3 years of Life Science / Biotechnology / Pharmacology / Information Systems experience OR
• Bachelor s degree and 3 to 5 years of Life Science / Biotechnology / Pharmacology / Information Systems experience OR
• Diploma and 7 to 9 years of Life Science / Biotechnology / Pharmacology / Information Systems experience.
• Must Have Skills
• Experience in creating and implementing validation protocols (e. g. , Installation Qualification (IQ), Operational Qualification (OQ).
• Solid understanding of GxP regulations, specifically 21 CFR Part 11.
• Expertise in defining and performing validation strategies aligned with regulatory requirements.
• Proficiency in automation tools, data systems, and validation software.
• Experience with Agile software development methodologies (Scrum).
• Excellent communication skills and the ability to collaborate with business domain experts, technology team members, GxP Systems Quality.
• Knowledge of Software Development Life Cycle processes, including requirements, design, testing, data analysis, change control.
• Good to Have Skills :
• Proficiency in automation tools, data systems, and validation software (Application Lifecycle Management and / or Veeva Vault Validation Management).
• Able to communicate technical or complex subject matters in business terms.
• Jira, HP ALM experience.
• Professional Certifications :
• SAFe for Teams certification (preferred)
• Soft Skills :
• Able to work under minimal supervision.
• Excellent analytical and gap / fit assessment skills.
• Strong verbal and written communication skills.
• Ability to work effectively with global, virtual teams.
• High degree of initiative and self-motivation.
• Ability to manage multiple priorities successfully.
• Team-oriented, with a focus on achieving team goals.

Skills Required

Automation Testing, Agile, 21 Cfr Part 11