Join the Lonza Team Hiring - Validation Specialist III - Onsite 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.
Job Requirements - Responsible for certain day to day activities conducted by the Validation Department and will act as lead for validation projects.
- Supports commissioning activities, projects, and validation functions by preparing, performing, and reviewing/approving validation protocols (IQ, OQ, PQ) and other documentation for equipment, facilities, and processes. Generates validation final reports.
- Perform temperature mapping on relevant equipment.
- Participates in audits and inspections conducted by internal and external entities, including agencies and clients. Liase with outside clients as a representative of validation.
- Can have tasks, deviations, CAPAs, observations, and change controls assigned in Trackwise. Manage to completion. May still need review and oversight.
- Assess and ensure the change management process is implemented and that appropriate validation activities are identified and performed, including computerized systems and software.
- Demonstrate knowledge of cGMP compliance and GAMP requirements.
- Coordinates activities for projects, the scope of which can be large and complex.
- Demonstrated ability to forecast and manage project work accurately and independently.
- Communicates validation activities and schedules to other departments as required.
- Oversee the activities of internal staff as well as external validation contractors on projects in which they are the lead. Establishes priorities to ensure that deadlines are met.
- Able to coach and mentor junior level specialists
- Able to correctly assess the impact to a study's acceptance criteria with input from supervisor / manager, as needed.
- Demonstrated ability to review policies or procedures for compliance.
- Able to assist in investigations with minimal oversight.
- Maintain professional and technical knowledge through continuous learning and training.
- Represents validation as an SME for one or multiple areas within validation.
- Monitors the performance of validation projects by tracking appropriate metrics and reporting the results to management.
- Support of Operational Excellence activities for department.
- Able to correctly understand and implement manager's intent based on the sound understanding of principles and feedback from manager.
- Perform other duties as assigned.
- Willingness to work after regular business hours including weekends when required.
Education Requirements: Associates degree preferred Will consider a combination of education and experience 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. Compensation for the role will depend on a number of factors, including the location of the successful candidate, qualifications, skills, competencies, experience, and job-related knowledge. Full-time employees receive a comprehensive benefits package including performance-related bonus, medical and dental coverage, 401k plan, life insurance, short-term and long-term disability insurance, an employee assistance program, paid time off (PTO), and more. 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.