Role Overview:The Lead GMP Validation Engineer will be responsible for leading the implementation and integration activities for GMP Quality Control (QC) systems. This role involves coordinating system configuration, data migration, deployment, and engaging with various stakeholders to ensure successful project execution and adherence to regulatory compliance.
Key Responsibilities:- Lead implementation and integration activities specifically for GMP QC systems.
- Coordinate system configuration, data migration, deployment, and manage stakeholder engagement throughout the project lifecycle.
- Conduct implementation kick-off sessions and actively drive project execution to meet objectives.
- Monitor project progress, identify and mitigate risks, manage timelines, ensure quality standards, and adhere to budget.
- Prepare comprehensive status reports to ensure transparent progress tracking for all stakeholders.
- Support Computer System Validation (CSV) and Computer Software Assurance (CSA) activities, including the execution and documentation of Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
- Collaborate effectively with Quality Assurance (QA), IT, business stakeholders, and external vendors to ensure full regulatory compliance.
- Ensure strict adherence to GxP, Data Integrity principles, and Roche validation standards.
- Support system acceptance, readiness for release, and go-live activities for new or updated systems.
Required Skills:- Possess 8+ years of experience within pharmaceutical, biotech, or other regulated GMP environments.
- Demonstrated strong experience with QC/Laboratory systems implementation and validation processes.
- In-depth knowledge of Computer System Validation (CSV), Computer Software Assurance (CSA), GAMP5 guidelines, and GxP regulations.
- Hands-on experience supporting IQ/OQ/PQ activities, conducting risk assessments, performing testing, and ensuring compliance.
- Proven experience in managing system integrations, data migration projects, and delivering cross-functional projects.
- Familiarity with various laboratory platforms such as LIMS, SDMS, Empower, SoftMax Pro, QuantStudio, LabX, or similar systems.
- Strong capabilities in stakeholder management, experience with Agile/Scrum methodologies, and excellent project coordination skills.
- Exceptional communication and documentation capabilities are essential for this role.
Qualifications:- 8+ years of experience in pharmaceutical, biotech, or regulated GMP environments.
