Website Katalyst Healthcares & Life Sciences
Katalyst Healthcares & Life Sciences
Company : Katalyst Healthcares & Life Sciences
Summary:
- The Lead Validation Engineer will oversee and drive commissioning and qualification (C&Q) activities for automation and process systems at a regulated manufacturing site.
- This leadership role is responsible for ensuring validation strategies align with regulatory expectations and project goals, while mentoring a team of validation professionals and coordinating with cross-functional stakeholders.
Roles and Responsibilities:
- Lead the planning, execution, and documentation of C&Q lifecycle activities (URS, DQ, IQ, OQ, PQ) for automation and process systems.
- Develop and implement validation strategies in alignment with quality standards and global regulatory requirements.
- Serve as the primary point of contact for validation-related matters across engineering, QA, manufacturing, and automation teams.
- Review and approve validation protocols, reports, and supporting documentation.
- Manage validation timelines, resource allocation, and risk mitigation plans.
- Provide technical leadership and mentorship to validation engineers and contractors.
- Support audits and inspections by presenting validation documentation and processes.
- Ensure compliance with cGMP, FDA, EU, and internal quality standards.
Education:
- Bachelor's or master's degree in engineering, Life Sciences, or related field.
- 10+ years of experience in validation within the pharmaceutical or biotech industry.
- Demonstrated leadership in managing C&Q projects and teams.
- Deep understanding of regulatory requirements and industry best practices.
- Proficiency with validation tools such as Kneat, GVault, or equivalent.
- Strong communication, organizational, and stakeholder management skills.
- Experience with large-scale C&Q projects in regulated environments.
- PMP or equivalent project management certification.
- Prior experience leading validation efforts in greenfield or brownfield projects.
- Life science Domain, Validation Skills, Delta V & MES Validation.