Senior Validation Engineer

Join to apply for the Senior Validation Engineer role at Katalyst CRO
.

Job Description

This position is responsible for planning, executing, and documenting commissioning, qualification, and validation (CQV) activities to ensure all systems meet stringent regulatory and client‑specific requirements. The Senior Validation Engineer will act as a subject‑matter expert, collaborating closely with cross‑functional teams, including Manufacturing, Facilities, Quality Control, and Quality Assurance to deliver robust validation strategies that enable compliant and efficient operations in an early‑phase clinical environment.

• Independently understand quality standards, cGMPs, and regulatory standards to support the team in compliance of validation effort.
• Author, edit, and execute technical commissioning, qualification and validation documentation for facilities, utilities, and standard equipment/systems/software.
• Actively consult clients on regulatory validation processes and standard industry acceptable practices.
• Collaborate with cross‑functional teams including Manufacturing, Facilities, Quality Control and Quality Assurance to ensure validation activities are properly scoped and executed.
• Take independent leadership role on project(s).
• Manage and work collaboratively with clients' quality representatives to complete deviation investigation and resolution for problems and issues encountered during execution activities. Includes ability to complete root cause analysis.

• Bachelor's degree in engineering, Life Sciences, or a related field.
• 5+ years of relevant experience in validation within a regulated industry (e.g., pharma, biotech).
• Experience with facility, utility, equipment, and computer system validation, preferably in start‑up or early‑phase clinical biomanufacturing facilities.
• Strong knowledge of validation principles, cGMP, FDA regulations (21 CFR Part 11, Part 210/211), and industry guidelines (e.g., ISPE, GAMP).
• Experience working with start‑up clients, without well‑established company procedures and standards.
• Excellent documentation, analytical, and problem‑solving skills.
• Ability to work independently and as part of a team.

Referrals increase your chances of interviewing at Katalyst CRO by 2x.