Principal Validation Engineer

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections,  where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.

The Position

A healthier future. It’s what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. That’s what makes us Roche. 

As a Principal Validation Engineer you will lead high-impact validation projects across equipment, facilities, and utilities within a cutting-edge regulated environment. In this role, you’ll write and execute IQ/OQ/PQ protocols, guide complex cross-functional initiatives, and apply Lean and Six Sigma principles to drive continuous improvement. You’ll work closely with cross functional stakeholders, while also mentoring junior team members and helping shape validation strategy from concept through execution.

The Opportunity

• Writes and executes Equipment, Facility, and Utilities Installation/Operational/Performance Qualifications (IQ/OQ/PQ) protocols on a variety of facility and manufacturing process equipment and analytical testing equipment in a full Biotech upstream/downstream manufacturing plant.  Qualification includes conception of qualification assessments, (basic to complex) protocol strategy, authoring protocols, execution, and final report writing.

• Leads and provides qualification and validation support to complex and/or multinational projects in his/her assigned area.  Participates and leads project planning, qualification/validation scheduling, process updates, and experimental design.  Assumes responsibility for timely completion of projects or assigned work, ensuring activities are consistent with project critical path and responding appropriately to changing priorities.

• Deep technical knowledge of qualification of equipment, facilities, and utilities.  Conceives, plans and conducts independent qualification/validation work or project work from inception through product launch and field support, defining schedules, and applying qualification or validation strategy that is robust and agile to complete projects.

• Apply Program Management tools to define and monitor project timelines, ensuring timely achievement of overall project goals and establishing priorities that are in line with the overall business needs.

• Utilizes Continuous improvement/Lean/Six Sigma manufacturing concepts to improve processes.

• Provides technical advice/guidance to junior scientific staff and leads project teams to solve business problems of moderate size risk and complexity and serves as an overall role model.

• Serves as an expert resource to other departments (e.g., Manufacturing/Operations, Development, Quality, Regulatory Affairs, and Technical Services), provides timely response and follow-ups.

Who you are

• You have a Bachelor's degree in an Engineering, Engineering Technology, or Life Science discipline. A Master's degree in one of these fields is preferred.

• You have 6+ years of relevant industry experience in Equipment and/or Facility Validation.  7+ years of experience is preferred. We will consider an equivalent combination of education and experience.

• A Master’s degree in Engineering may qualify with 6 or more years of experience in complex mechanical or chemical systems development and validation.

Knowledge, Skills and Abilities

• Solid understanding in the manufacture of assays, reagents and instruments as well as Verification and Validation principles, practices and tools used in that transfer.

• Proven ability to work on complex problems with analysis of situations or data towards successful outcomes.

• Demonstrated ability to apply Lean and 6 Sigma methodology in all that you do and a passion to drive It throughout the organization

• Proven ability to contribute and interact productively and collaboratively with project teams.

• Excellent verbal communication skills required. Excellent interpersonal skills required to interact with stakeholders such as system owners, quality assurance, and auditors.

• Excellent technical writing skills required. Studies, protocols, reports, deviations, and non-conformances must be written in a clear, structured manner direct