CSV Engineering

United States, Houston (Texas)

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’s Cell and Gene Therapy Facility is the largest in the world and our facility is growing. We are looking for professionals to grow with us and we have this exciting opportunity at our Houston site. 
Maintenance of the Computer Systems Validation (CSV) program. Serve as a CSV subject matter expert, track and report action plan status/ completion as it relates to validation systems improvement efforts. Responsible for managing the development and the execution of qualifications, validations, re-qualifications and re-validations for process equipment, utilities and facilities, focusing on the computer validation aspects of the systems.


Support ongoing site wide projects by collaborating with experienced members of the Validation, Engineering, Operations and QA teams to identify road blocks and additional efficiencies.  Additional daily responsibilities include performing and documenting risk assessments of systems and processes, assessing change proposals, drafting protocols, evaluating deviations/change controls and initiating revisions of GMP documentation related to computer systems.

Key responsibilities:
•    Generates and executes (as applicable) User Requirements, Design Specification, Functional Specification and Traceability Matrix. Produces Validation Plans, IQ/OQ/PQ Protocols, test scripts, and SOPs as required to meet 21 CFR Parts 210, 211, 11, EU Annex 11, GAMP 5 and ISO 13485:2003 requirements among others.
•    Develops CSV Gap Assessments and Remediation Plans with an understanding of applying risk management principles.
•    Supports regulatory and client audits as CSV subject matter expert.
•    Able to work independently (author protocol, execute studies, analyze data, author reports).
•    Advanced knowledge of discipline; able to discuss regulatory expectations for validation activities, program and documentation.
•    Able to handle some larger and more complicated project work, with oversight at a moderate degree.
•    Demonstrated ability to plan and organize validation activities among cross functional groups; capable of providing and maintaining status updates for validation activities related to day-to-day operations or project work.
•    Capable of independently discussing computer systems validation philosophies during customer audits or regulatory inspections in the presence of senior management. Capable of correctly answering questions about day-to-day activities that would be most likely posed by Validation Engineer I-IV level personnel. Supports implementation of site-wide/departmental projects and initiatives.  
•    Develops, monitors, and reports metrics for computer systems validation activities for individual projects.  
•    Generates CSV Assessment Forms for new equipment and existing equipment (if applicable).
•    Participates in the initial assessment of change controls for process, laboratory, classified facilities and clean process utilities.  Assessment primary focus being in the CSV portion of the system/equipment. 
•    Performs validated equipment/systems periodic review.  
•    Generates periodic review reports.

Key requirements:
•    Bachelors degree in Science or Engineering required
•    Highly experienced in Computer Systems Validation
•    Thorough knowledge of validation life cycle, validation protocols (IQ/OQ/PQ) generation and execution of manufacturing and laboratory equipment, clean process utilities and classified facilities
•    Fundamental understanding of validated computer systems and change management in the commercial pharmaceutical/biotech industry, including training others.
•    Proficient in the use of spreadsheets, databases, and word processing software.
•    Performs statistical analysis of data.
•    Knowledge of SAP and TrackWise systems a plus.
•    Uses experience and knowledge to solve problems, make decisions, and develop plans for the group.  Makes recommendations for the department.  
•    Able to identify and respond to complex problems, interpret complex data and draw valid conclusions.
•    Improves efficiency of self and team by clearly defining and analyzing problems and implementing new ways of approaching work.  
•    Proficient at establishing clear and understandable directions and goals.  Provides and implements suggested resolution to roadblocks.
•    Able to prioritize own work and aid in setting group priorities
•    Able to write complex procedures and reports.  
•    Able to communicate status, needs, forecasts, risks and timelines effectively to management.
•    In conjunction with program management team, helps develop loyalty and trust with customers.  
•    Motivates team to be flexible and to respond to planned and unplanned or unanticipated changes with speed and confidence.   
•    Demonstrated leadership skills as well as team building and mentoring skills.
•    Leads by example – models good behavior, work ethic, and teamwork.  

Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment.

Any success we achieve is no success at all if not achieved ethically. 

People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.

Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law. 

Reference: R33098