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.

The Manager, Engineering Validation manages successful completion of Validation projects within boundaries of quality, time and budget supporting product manufacturing efforts for the site. Based on technical expertise, reviews and approves validation protocols. Manages and provides technical direction to reporting disciplined engineering validation staff members and external contracted validation resources. Display an understanding of theories/practices of a variety of engineering validation principles and requirements.

Key Responsibilities:

• Manages, develops, and executes site required validation objectives and Validation Master Plan.
• Manages, identify, hires, develops and recognizes validation staff both reporting and contracted.
• Provides technical direction as required.
• Responsible for policy setting and defining procedures for staff in accomplishing and documenting projects.
• Provides input on overall engineering department policy.
• Financial responsibility for both validation departmental and capital expenses.
• Reviews and approves validation feasibility of design concepts and analysis of technologies that incorporate area of experience.
• Reviews and analyzes validation proposals, protocols and technical reports to determine if benefits derived meets GMP validation requirements.
• Develops and recommends validation approaches for strategy concurrence, consideration, and allocation of personnel and funds.
• Responsible for preparation of validation cost and resource estimates for site projects.
• Monitors and manages OpEx expense and validation costs.
• Responsible, through management of subordinates, for defining and managing validation scope of work.
• Responsible for policy setting and defining procedures for the staff in accomplishing and documenting projects.
• Approves protocols, reports, support documentation (Commissioning, IOQ, PQ, PPQ ) to secure project release, execution, and closure.
• Manages a variety of complex matters in associated departmental Validation projects, provides guidance, direction to plans and schedules for project implementation.
• Applies statistical analysis and design of approaches to process development validation activities.
• Proactively communicates directly and regularly with site Quality, Engineering, and other site functions, ensuring local consistency for Validation Engineering methods and initiatives.

Key requirements:

• High School Diploma; BS in relevant engineering discipline; BSME, EE or Chem E. Preferred area of study: Engineering.

• 2 to 4 years’ experience managing validation personnel reporting staff.
• 4 - 8 years’ experience within the regulated GMP industry Validation Engineering group, writing and performing equipment and process validations, IOQ, PQ, PQ, PPQ and Technical Reports.

• ASQ Certification; Pharma GMP Professional (CPGP) preferred.
• Demonstrates an ability and desire to learn from experience and develop
• Understands the impact of his/her own actions on his/her business area.
• Uses knowledge of his/her business area to make accurate and timely decisions
• Understands what internal and/or external customers need from him/her to deliver in his/her respective role
• Demonstrates persistence and motivation to overcome obstacles and challenges. Plans, prioritizes and organizes work to deliver on time
• Contributes to a positive work environment. Acts as a reliable and dependable member of the team

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: R46478