Responsibilities
Act as Validation and Qualification Lead on a large laboratory remediation projects, with specific focus on Laboratory Standalone COTS systems
Author the typical validation, qualification, and testing documentation such as Validation Plans/Summaries, Test Plans/Summaries, User Requirements, Configuration Specifications, Trace Matrix, Qualification Protocols (IQ/OQ/PQ) and Scripts, Testing Defects, etc.
Assist systems users with defining, authoring and documenting system use in user, admin, and maintenance SOPs
Coordinate alignment of systems users from various company groups on validation and qualification documentation
Proactively communicate with various company organizations and systems vendors to ensure the project hurdles are overcome quickly and effectively
Provide tactical guidance and coaching in support of systems testing efforts with the stakeholders
Act as validation task lead: take ownership of related tasks, work under minimal supervision, utilize the industry experience and best judgment to make tactical decisions, stay proactive, etc.
Support the review & approval of key quality deliverables including SDLC, Change control, Deviations, CAPAs. Etc.
Attend periodic review meetings, cutover migration, hyper care support, any enhancements planning, design and/or implementation meetings as required.
Good at customer handling and liaising with all stakeholders.
Qualifications & Education
5+ years of Lab Systems validation experience is required.
Specific hands‑on experience with validating, qualifying, and/or using Pharmaceutical QC Lab Standalone COTS systems are required, including the authoring end‑to‑end of life cycle documents (including systems use and administration procedures)
Understanding of Data Integrity concepts is required
Excellent communication and written skills required
You have strong analytical skills and an aptitude for decision‑making
You show resilience when faced with challenges
You believe in continuous learning and growth
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