CSV Engineer

HCL Technologies Limited; Dunboyne; On-site; EUR 80,000 - 110,000; Full time

Job summary

HCL Technologies Limited is seeking a Validation and Qualification Lead for large laboratory remediation projects, with emphasis on Lab Standalone COTS systems. You will author end-to-end validation and testing documents and guide users across multiple teams.

Responsibilities include coordinating validation workstreams, communicating with vendors, and mentoring on testing approaches. The role requires strong data integrity knowledge, excellent communication, and a proactive problem-solving

Qualifications

• 5+ years of Lab Systems validation experience is required.
• Hands-on validation/qualification of Pharmaceutical QC Lab Standalone COTS systems and lifecycle documents.
• Understanding of Data Integrity concepts is required.
• Excellent communication and written skills required.
• Strong analytical skills and aptitude for decision-making.
• Resilience when faced with challenges; growth mindset.

Responsibilities

• Act as Validation and Qualification Lead on large lab remediation projects, focusing on Lab Standalone COTS systems.
• Author validation, qualification, and testing documentation (Validation Plans/Summaries, Test Plans, URs, Config Specs, Trace Matrix, IQ/OQ/PQ, scripts).
• Assist users in defining and documenting system use in SOPs (user/admin/maintenance).
• Coordinate alignment of system users from multiple groups on validation docs.
• Proactively communicate with stakeholders and vendors to remove project hurdles quickly.
• Provide tactical guidance and coaching in system testing efforts.
• Lead validation tasks and own related activities with minimal supervision.
• Support review/approval of SDLC, Change Control, Deviations, CAPAs, etc.
• Attend meetings on cutover, hyper-care support, enhancements planning, and implementation.
• Maintain strong customer liaison and stakeholder relationships.

Skills

Lab Validation

Stakeholder communication

Analytical thinking

Decision making

Resilience

Continuous learning

Job description

• 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