Validation Engineer

Job DescriptionOverview:Writes and executes validation plans and protocols. Performs qualification and validation status assessments. Responsible for driving completion of validation activities, including writing, and reviewing protocols, executing and/or coordinating protocol execution, and writing final reports. Primary Responsibilities: Provide guidance and execute validation activities for manufacturing equipment, utilities, automation, cleaning, and sterilization validation to support the manufacturing facility projects and keep the facility in a validated state. Represent Validation Group on project teams and report progress and adherence to the schedule, as required. Ensure proper validation protocols and reports are developed and followed to ensure compliance with LMI validation guidelines, pharmaceutical industry requirements and regulations (e.g., FDA, EMA, PIC/S). Work independently to collect, organize and evaluate validation data and keep validation management informed of progress and any obstacles. Proactively review validation status of current equipment, systems, utilities, and facilities to perform documented periodic validation assessments, risk analyses and identify remedial activity. Participate in project team meetings to represent Validation to meet established timeframe for project that support business needs. Support inspection readiness, participate in regulatory agency inspections and provide audit support, as required.Education & Qualifications: BS degree in science or engineering and a minimum of 5 years validation experience in the pharmaceutical or biopharmaceutical industry. Hands on validation experience with pharmaceutical manufacturing equipment including sterilizers, parts washer, depyrogenation ovens and tunnel, HVAC, controlled environmental chambers and pharmaceutical utilities. Including experience conducting temperature mapping. Aseptic fill-finish experience, including familiarity with validation of vial filling line and aseptic manufacturing technologies and facilities is a plus. Demonstrated proficiency and knowledge of CGMPs, pharmaceutical industry validation practices, and change control practices required. Demonstrated ability to effectively write technical documents, including test plans, protocols, and reports. Experience using project management tools (Microsoft office Project, Visio,) is a plus.

Created: 2025-10-04