Website Katalyst Healthcares & Life Sciences
Katalyst Healthcares & Life Sciences
Company : Katalyst Healthcares & Life Sciences
Summary :
Top 3 must have's: Life science Domain, Validation Skills, Delta V & MES Validation
Roles & Responsibilities:
• Lead and manage C&Q lifecycle activities including URS, DQ, IQ, OQ, and PQ for automation and process systems.
• Collaborate with cross-functional teams including engineering, QA, manufacturing, and automation to ensure validation deliverables align with project timelines.
• Develop and review validation protocols, reports, and supporting documentation in compliance with FDA, EU standards.
• Utilize tools such as Kneat, GVault, or equivalent systems for document control and validation tracking.
• Provide technical guidance and mentorship to junior validation engineers and contractors.
• Support change control processes and deviation investigations related to validated systems.
• Participate in audits and inspections, providing subject matter expertise on validation practices and documentation.
• Ensure alignment with the overall execution and resource plan as outlined in the C&Q strategy.
Education & Experience:
• Bachelor's or master's degree in engineering, Life Sciences, or related field.
• Minimum 7+ years of experience in validation within the pharmaceutical or biotech industry.
• Strong knowledge of cGMP, FDA, ICH, and EU regulations.
• Proven experience with commissioning and qualification of automation systems.
• Proficiency in validation tools such as Kneat, GVault, or similar platforms.
• Excellent communication, documentation, and project coordination skills.
• Experience working on large-scale C&Q projects in a regulated environment.
• Familiarity with systems and validation practices is a plus.
• PMP or equivalent project management certification.