Process Validation Scientist III

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.

Job Summary:

The MSAT Process Validation (PV) Scientist III is responsible for performing tasks related to Process Validation activities, as well as general PV support, with supervisory direction. The PV Scientist III performs a variety of routine work within established policies and procedures, and receive detailed instructions on new projects and assignments. You're expected to have the knowledge and aptitude to perform routine assignments and is expected to independently solve problems or collaborate to solve the problem to the best of their ability. Questions on tasks or issues will be raised by this individual when clarification or greater technical expertise is required.

Key Responsibilities:

• Able to work with minimal assistance and supervision on basic PV techniques of protocol development, execution, and reporting to ensure technical content is sufficient and accurate

• Make protocol decisions (i.e. conclusions, product impact / validation impact assessment, corrective actions) without review of a higher-level PV scientist or Manager. Understands the role of specifications, acceptance criteria, and sample plans within PV protocols and is able to escalate the appropriate quality system response, as required

• Knowledgeable of disciplines including standard industry guidance and in depth understanding of the intent and philosophy of the validation exercise

• Note: This includes, but is not limited to, the following:

PV Activities: ​PVP Generation, PPQ Protocols, Large Scale Resin Lifetime, UF Membrane Lifetime, Mixing Validation, Media Pre-Filtration, Impurity Clearance, Intermediate Microbial Hold, Reprocessing Protocols, BPC Hold Studies, CPV, and PQR

Discrepancies: Able to generate process validation discrepancies or investigations to ensure root cause, product/validation impact, and corrective actions are accurate

Change Management: Qualified to perform process change control assessments

Deviations: Able to assist on deviations and provide guidance on validation impact with minimal assistance

CAPA: Able to generate process validation CAPA that are not the result of regulatory findings SOPs: Author, review, and revise procedures independently

• Represents PV on internal and external project teams. Interfaces with customer technical and quality representatives on study related work. Provides regular updates on study related progress

• Facilitates inspection readiness, seeks development opportunities for agency inspections and audits to include backroom and front room support with supervision, as required.

• Follows all training and policy guidelines established for the facility as well as all cGMP requirements. Ensures employee training profile is up to date at all times by regular monitoring of training lists (e.g. Compliance Wire, Cornerstone Learning Portal) and completing all training in a timely fashion

• Perform other duties as assigned

Key Requirements

• Bachelor of Science degree required, field of Study: Chemical Engineering, Mechanical, Biology, Biochemistry is preferred.  Other life science degrees are acceptable

• Minimum 5 years of biotech industry experience (3+ with Masters degree, 2+ with PhD degree) in process validation, process development, quality, or manufacturing

• Experience with large scale manufacturing support (mammalian preferred), current Good Manufacturing Practices, US / EU regulations

• Requires basic understanding of all applicable QC assays e.g., assay purpose, procedure, major results

• Strong communication, technical writing, organizational and interpersonal skills; Strong computer skills (including Word, Excel, Outlook and PowerPoint.)

• Analytical and problem-solving skills; Attention to detail and high level of accuracy

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.