Validation Engineer III
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 CGT site. The Validation Engineer will be responsible for the writing of and the execution of project and system qualifications, validation, re-qualifications, and revalidation of manufacturing facilities, equipment, utilities, computer system, and processes.
Implementation of Validation Activities
- Able to work independently (author protocol, execute studies, analyze data, author reports).
- May require some guidance from more senior specialists on larger or more complex tasks or issues; beginning to be able to handle small projects independently or with some oversight.
- Intermediate level knowledge of discipline to include regulations, guidance documents, and understanding of the purpose of all the different documents in our lifecycle system..
- Able to perform investigations into causes and assess impact on validation taking into account other disciplines and process/product, but needs review and oversight from others.
- Able to identify potential root causes with assistance or investigation and cooperation from other departments. It is not anticipated that a Specialist III can correctly scope and analyze all causes and impacts, but should be able to for simple-to-moderately complex items.
- Able to write sound discrepancy reports that close loops as required. Will, the majority of the time be able to correctly assess the impact to a validation study’s acceptance criteria.
- Demonstrated technical writing skills and moderate understanding of root cause analysis.
Documentation (SOPs, VMPs, Deviations, etc)
- Author/Modify templates
- Author deviations and validation protocol final reports.
- Assess impact of process/equipment or procedural changes that can affect the validated state of the equipment with some guidance and oversight
- Author/review independently.
- Intermediate knowledge of GMPs and their application.
- Familiarity with regulatory guidance’s applicable to equipment/cleaning validation, computer system, and process validation.
Equipment, Technical and Process Expertise
- Training is everyone’s responsibility (being trained and being proactive in getting trained)
- It is an expectation that everyone who is trained, lends their knowledge in getting others trained.
- Working in safe manner is an expectation and safety training must be up to date.
Systems and cGMP Expertise
- GMP is everyone’s responsibility; support for all operational areas is an expectation with appropriate follow up on any validation issues
- Protocol generation is every validation member’s responsibility. If not qualified, specialists should participate in this expectation by co-writing with a qualified specialist.
- Must demonstrate a fundamental knowledge of rudimentary biotech applications (such as process monitoring, etc)
Problem analysis/Decision making
- Must understand root cause analysis for use in problem solving and decision making.
- Ability to work in a cross functional group as needed to resolve general equipment or manufacturing deficiencies.
- Expresses values of the company in a positive manner.
- May be required to work off-shift or weekends to support manufacturing operations.
- Everyone will have multi-departmental communication.
- Constructive proactive communication is expected.
- Instruction may be provided by co-workers, supervisors, or cross-departmental representative to facilitate continued production within GMP guidelines.
- Support of Operational Excellence activities for the site.
- Support the maintenance and organization of the validation lab and validation equipment and office.
- Bachelors Degree Required
- Positive team oriented attitude.
- Excellent work record (includes tardiness and absenteeism record with the guidelines of the employee handbook)
- Proven ability to work independently.
- Demonstrated ability to present issues in both a written and verbal manner.
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.