Lead, PMO & Validation - lonza : Job Details

PMO & Validation Lead

Today, Lonza is a global leader in life sciences operating across five 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.

Be a part of Lonza AG as a PMO and Validation Lead and contribute significantly to our bold mission of providing premier life science solutions. This outstanding opportunity in Greenwood, SC, USA, allows you to effectively implement innovative ideas that have a tangible impact.

Key responsibilities:

* Provide direction to project teams on compliance and technical issues related to validation efforts, ensuring magnificent execution in alignment with regulatory requirements.

* Lead the Master Validation Plan and ensure all validations and qualifications are completed and revalidated rigorously to timelines.

* Design, complete, and conclude studies related to process, cleaning, systems, and laboratory method and equipment validations.

* Ensure large-scale Hard Capsule projects are completed successfully using the Stage-Gate project management process.

* Lead New Product Development qualifications, including new material characteristics and polymer formulations.

* Coordinate cross-functional validation projects with QA, QC, Engineering, Technical Services, and Operations.

* Develop and maintain validation documents, including IQ, OQ, and PQ protocols and reports.

* Assess and determine capability between benchmark and post-validation for modified product or process parameters.

* Update Quality Systems functions, such as Risk Management and Risk Register, upon validation completion.

* Act as a liaison and resource for global validation efforts.

* Approve all requests for change activities plant and region-wide, ensuring risk assessments are completed and validations are performed when necessary.

* Mentor and lead colleagues involved in validation activities to ensure adherence to accurate procedures.

Key requirements:

* Validated experience in a product management role within the life sciences industry.

* Strong understanding of validation processes and regulatory requirements.

* Outstanding capability to independently resolve and communicate technical issues.

* Experience with New Product Development and Stage-Gate project management.

* Ability to lead cross-functional teams and coordinate complex projects.

* Excellent documentation skills, including the creation of IQ, OQ, and PQ protocols.

* Strong analytical skills to assess capability and determine process improvements.

* Proven track record of mentoring and leading teams.

* Dedication to inclusion, collaboration, and achieving flawless execution.

Education Requirements:

* BS / BA Engineering or Science

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.