Senior Validation Engineer

Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.

Lonza Houston is looking for a Senior Validation Engineer to support the QA/Validation Engineering group.

POSITION: Senior Validation Engineer

LOCATION: 14905 Kirby Dr., Pearland TX 77047 (& various unanticipated locations throughout the US; may work from home)

DUTIES: Develop validation plans, qualification protocols, compile & analyze data, and review validation documentation to ensure that systems are qualified in accordance with applicable regulatory agencies, clients and Lonza specifications. Lead and assess Change Controls for new product and process equipment into the Lonza Houston facility with an accurate understanding of implications of changes, review, oversight and feedback. Generate, assess and perform root cause investigation on Deviations that affect validation. Work and document on Corrective Action Preventive Action (CAPA) that result from deviations, internal audits, protocol discrepancies, global quality audits or regulatory inspections. Responsible for the development and the execution of qualifications, validations (Mechanical and Computer system Validation), re-qualifications and re-validation for process equipment, laboratory equipment, utilities and facilities. Assist and support the validation manager with the supervision of assignments given to the validation group to ensure projects maintain a satisfactory level of quality, function efficiently and operate in accordance with established procedures. Analyze functional specification and any documentation that exists for the validation project assignment. Schedule meetings with technical, development and users departments as necessary to obtain clarification on project scope to ensure a successful project implementation. Develop, generate, review, execute, maintain and implement a validation project plans, validation protocols (IQ/OQ/PQ), summary report as required by Lonza site’s validation master plan, Standard Operating Procedures (SOPs) and global policies and implement them to ensure a successful validation project. Coordinate technical activities regarding validation including protocol development, synchronization of interdepartmental activities, evaluation and reporting results. Identify and report any deviations, quality issues and discrepancies based on data from a variety of sources. Responsible for recommending and verifying implementation of appropriate corrective action for validation execution issues in coordination with program management, engineering, purchasing, and change control management. Provide support to management for interface on validation activities and validation executions. Provide technical guidance to lower-level validation personnel. Track and report action plan status and completion as relates to validation system. Plan and organize qualification, validation and verification activities amongst cross functional groups. Analyze and interpret validation test data to determine whether systems or processes have met validation criteria or to identify root cause of discrepancies and deviations.  Apply knowledge of validation lifecycles for manufacturing equipment, facilities and process utilities validation. Utilize Validation Life Cycle (VLC), Validation Master Plan (VMP), Validation protocols (IQ/OQ/PQ and summary reports), Standard Operating Procedures (SOPs),  and Process Validation. Work on validating Incubators, Biological Safety Cabinets (BSCs), Autoclaves, Laboratory Freezers, precision balances, platform shakers, centrifuge, room qualification and validating equipment in classified Clean Rooms/HVAC. Perform statistical analysis of data, temperature mapping, smoke studies, execute validation protocols, execute installation qualification activities, execute operational qualification activities and execute performance qualification activities.  Utilize Lab equipment, KAYE Equipment and ELLAB Equipment. Utilize Data Management System (DMS) Spreadsheets, Validations Tracker spreadsheets, Fieldglass, Word processing software, SAP and Trackwise systems. Utilize Root Cause Analysis, Continuous Improvement, Failure Mode Effective Analysis (FMEA) and Corrective Action & Preventive Actions (CAPA).

REQUIREMENTS: Requires a Master’s degree, or foreign equivalent degree, in Engineering Management or Engineering and 1 year of experience in the job offered or 1 year of experience in a related occupation applying knowledge of validation lifecycles for manufacturing equipment, faciliti