Senior Validation Engineer

Job summary

The Senior Validation Engineer is responsible for leading and managing commissioning, qualification, and validation activities for manufacturing processes and equipment. This role ensures compliance and lifecycle management of validated systems while serving as a key technical authority in various projects.

Qualifications

• Proven experience in validation engineering within a regulated environment.
• Strong understanding of cGAMP standards and regulatory requirements.
• Experience in developing User Requirement Specifications (URS) and validation protocols.

Responsibilities

• Lead the development of URS and oversee the selection and implementation of manufacturing processes and equipment.
• Ensure compliance with design documentation and facilitate Equipment Design Reviews.
• Manage deviation activities during Commissioning and Qualification phases.
• Drive validation lifecycle activities, including qualification and revalidation strategies.
• Provide technical leadership and mentorship to cross-functional teams.
• Support audit readiness and manage Non-Conformances and CAPAs.

Skills

• Strong analytical and problem-solving skills.
• Excellent communication and collaboration abilities.
• Proficient in risk management and project planning.

Education

• Bachelor's degree in Engineering, Life Sciences, or a related field.

Tools

• Familiarity with validation software and documentation tools.