Associate Director, Validation
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 Walkersville is hiring an Associate Director, Validation. This individual is responsible for setting strategy and policies and oversight of the Lonza Walkersville validation department and programs. Overall accountability for the validation program including: initial qualification, computerized system validation, sterilization validation, cleaning validation, aseptic process simulation and requalification of facilities, equipment, cleanrooms.
- Performs strategic planning and development of activities for site qualification and validation including compliance, capacity, timelines and directions.
- Collaborates closely with senior leadership team in meeting corporate and organizational goals through establishing and reporting of department or organizational metrics.
- Performs and ensures validation of GMP facilities through management of validation projects of various sizes while providing technical assistance. Acts as subject matter expert and resource to direct reports, peers and colleagues.
- Establish, generate, and maintain department procedures in compliance with company and industry standards.
- Owns and maintain the validation master plans and program quality systems.
- Develops Validation Plans for validation projects and oversee contract staff, when necessary, through development of statement of work and vendor selection.
- Write, review and approve associated qualification and validation protocols and reports including executed protocols. Ensures appropriate resolution of protocol exceptions.
- Generate, review and approve deviations, CAPAs. Perform/ lead investigations and RCAs as required.
- Perform change control assessments.
- Primary point of contact for audit requests. Present and defend validation studies during regulatory, customer and internal inspections.
- Authors or reviews validation section of annual periodic product reviews.
- Lead or participate in risk assessments and gap analysis.
- Lead continuous improvement initiatives
- Assign work to direct reports including new projects and initiatives, prioritize work based on business needs, impact to quality and safety, and employee development
- Guide direct reports through technical challenges and escalation of issues
- Conduct regular 1-on-1’s with employees to check progress on work objectives
- Assist with development of employees to help employees achieve career goals
- Perform mid-year and year end performance reviews with employees
- Accountable for technical work of direct reports
- Manage training for staff
- Perform other duties as assigned.
- Bachelors Degree in Science or Engineering is required.
- GMP compliance knowledge, EU Guidelines, FDA Guidance on Aseptic Processing.
- Comprehensive knowledge of validation lifecycles for computerized systems, aseptic processing, sterilization validation, cleaning validation, equipment/utility validation.
- Thorough understanding of industry standards, best practices for computer system validation, such as GAMP, FDA 21 CFR Part 11 compliance.
- Experience with cleanroom, facility and validation of advanced processing equipment including isolators, filling lines, freeze dryers, autoclaves, AHU and utilities.
- Familiar with sterilization, bio-decontamination and material compatibility.
- Superior communication, strategic, interpersonal, and negotiating skills. Able to provide advice as overall validation subject matter expert and openly communicate any relevant issues.
- Demonstrated project management abilities to lead and manage a high volume of simultaneous projects.
- Team oriented, successful experience managing high performing teams and coaching employees
- Excellent written and oral communication to include accurate and legible documentation skills.
- Ability to work in a fast paced environment
- Microsoft Office skills, organization, record keeping
- Strong collaboration and communication skills required.
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.