Senior Validation Engineer
Description
Senior Validation Engineer
Main Purpose:
The Senior Validation Engineer is responsible for creating and executing computer system validation (CSV) and regulated software development activities and documentation to assure compliance across the technical portfolio of Marken and thus ensure conformance to cGxPs, guidance documents, and applicable industry accepted standards.
Main Duties and Responsibilities:
- Provide interpretation, guidance, and training regarding qualification and validation requirements in a GxP environment, including 21CFR11, Predicate Rules and General Principles of Software Validation (such as GAMP 5 Compliance).
- Participate in software platform project teams and author, review and approve computer validation related documentation including but not limited to: risk assessments, validation plan, user requirements, specifications, UAT, traceability matrix, testing (IQ/OQ/PQ), data migration, qualification/validation protocols and validation summery reports.
- Participate/lead in the review of current and future SDLC/CSV policies and procedures.
- Support initiatives related to audit readiness, management of internal/external audits as well as regulatory inspections, and responding to findings in areas of responsibility.
- Demonstrate strong proficiency in applying established tools and methods (for example, Six Sigma, Lean) to identify and realize new product or process introductions, as well as process and business improvements.
- Implement, and/or maintain process software quality control plans that are in accordance with product or process risk level, and ensures those plans are consistently followed.
- Actively coach talent across the tech organization on quality principles.
- Partner with business SMEs and training to prepare user documentation and training materials.
- Other duties as assigned by the IT Manager
Requirements:
- 5+ years IT software testing and validation and experience of increasing project size and complexity. Strongly preferred experience within the life sciences and/or logistics and supply chain industry,
- Bachelor's degree; specialization in IT, Management Information Systems (MIS) or Science related disciplines.
- Strong knowledge of FDA regulations and experience in implementing 21 CFR Part 11 and regulated Software Development Life Cycles.
- Knowledge of CSV requirements (IQ/OQ/PQ).
- Strong analytical skills
- Ability and desire to work in a fast pace, dynamic environment
- Strong Time Management, Organization and Execution Skills
- Strong written, verbal and presentation communication skills
- Strong collaboration skills required to effectively work across a diverse group including executives, managers and Subject Matter Experts (SME)
- Effective interpersonal and conflict resolution skills
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