Sr. Validation Engineer

Opdrachtgever

Our client is a leading Project Management and Engineering company serving the pharmaceuticals industry around the world.

Bachelor’s or Master’s degree in Engineering, Life Sciences, or a related technical discipline.
Min 5 years of experience in commissioning, qualification, and validation within a GMP regulated environment. 10 years or more preferred.
Demonstrated experience validating equipment, utilities, facilities, and computerized systems.
Hands on experience executing IQ/OQ/PQ and managing validation documentation.
Strong knowledge of GMP and GxP requirements.
Familiarity with regulatory expectations from authorities such as FDA and EMA.
Experience applying risk based validation and quality risk management principles.
Ability to work independently while integrating smoothly into cross functional teams.
Experience working with external vendors and contractors.
High level of accuracy, attention to detail, and documentation discipline.
Validation/qualification of (analytical) equipment, including both (writing) documentation and execution.
Knowledge of CSV principles, data integrity, and risk-based validation approaches.
Operating within a GMP / CAR T cell environment.
Effective communication, with a strong analytical mindset and attention to detail.

Validation & Qualification Execution

Create, review, and approve qualification protocols (including vendor protocols), executed protocol summary reports, and Requirements Traceability Matrices (RTM) for equipment, utilities, facilities, and computerized systems.
Develop, review, and approve Validation Project Plans and Validation Summary Reports.
Plan, execute, review, and approve commissioning and qualification activities (IQ, OQ, PQ), including the investigation and resolution of deviations and exceptional conditions.
Witness and oversee vendor commissioning and qualification activities as required.
Support and maintain the periodic review program for validated systems.
Perform and approve periodic evaluations to confirm the ongoing validated state of systems.

Project & Stakeholder Collaboration

Actively participate in multidisciplinary teams as a CQV team member or CQV lead.
Establish CQV strategies and approaches during planning, design, and execution phases.
Collaborate closely with Manufacturing, Engineering, Quality, and external vendors to align validation activities.
Support the introduction, qualification, and lifecycle management of new equipment and technologies used in manufacturing.

Risk, Change & Compliance Management

Review and approve validation related deliverables such as System Impact Assessments, URS, FRS, configuration and design specifications, and risk assessments.
Assess change controls for validation impact and define required qualification activities.
Participate in deviation investigations, root cause analyses, and CAPA development and implementation.