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 has an exciting opportunity for a Validation Manager. This individual will support the Head of Validation by ensuring effective implementation and maintenance of the validation program. Serve as a Validation 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.
Support ongoing site wide projects by collaborating with experienced members of the 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 validation.
- Responsible for the day to day activities conducted by the Validation department. Supervises the validation department personnel, coordinates activities for the department and supervises the validation program. Demonstrated ability to forecast and manage project work correctly and independently; able to be an independent interface to other portions of the organization as assigned, providing updates as requested and seeking out higher level input when it is necessary; scope of projects managed is large and complex; able to correctly understand and implement manager’s intent based on sound understanding of principles and feedback from manager. Able to supervise junior level specialists, as necessary. Capable of discussing validation policies and philosophies during customer audits. Demonstrated ability to review policies or procedures for compliance with regulatory guidance.
- Able to correctly assess all change controls with an accurate understanding of the bigger picture implications of changes. May still need some review and oversight or feedback.
- Oversees the site Validation Master Plan, using input from internal and external resources for continuous improvement. Creates, coordinates, and enforces Lonza’s Validation systems, policies, and procedures.
- Liaise with outside clients as a representative of validation. Participates in audits and inspections conducted by internal and external entities.
- Supervises the activities of the internal validation staff as well as external validation contractors. Establishes priorities to ensure that deadlines are met and budgets are not exceeded.
- Clearly define job expectations to subordinates. Coach, counsel and discipline employees as warranted. Maintain adequate staffing levels for the department and workload.
- Bachelors in Science or Engineering
- Highly experienced within Mechanical Engineering
- Highly experienced within the Biopharmaceutical industry is required
- 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 and change management in the commercial pharmaceutical/biotech industry, including training others.
- GMP compliance knowledge including knowledge of 21 CFR Parts 210, 211, 11, EU Annex 11, GAMP 5 and ISO 13485:2003 requirements, among 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.
- Demonstrated experience in management of complex tasks and projects.
- Able to write complex procedures and reports.
- Able to communicate status, needs, forecasts, risks and timelines effectively to management.
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.