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As a Manager, Validation Engineering, you will oversee the end-to-end validation lifecycle for new and existing manufacturing equipment in a regulated environment. This role is responsible for managing a team of Validation Engineers and Specialists, ensuring that all validation activities comply with regulatory requirements and support manufacturing readiness. You will collaborate closely with managers across all engineering disciplines to ensure that user requirement specifications and critical process parameters are clearly defined and verifiable during validations, enabling proper equipment functionality.

The Opportunity

Develop and execute comprehensive validation plans for new automation equipment, including Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).

Own validation deliverables for major capital projects, ensuring on-time readiness for production launch and audit support.

Partner with Automation, Process Engineering, QA, Manufacturing, and vendors to align validation timelines with production and project milestones; support change control assessments and participate in design reviews to ensure equipment and processes are developed with validation requirements in mind.

Present and discuss data, present alternative action plans, and clearly communicate recommendations to engineering teams and management.

Maintain validation program health through periodic review, revalidation strategy, and continuous improvement initiatives.

Serve as the validation SME during internal and external audits (e.g., FDA, ISO, Notified Bodies).

Responsible for maintenance of engineering Software tools and laboratory equipment and related agreements contract management.

Monitors work to ensure quality and continuously promote Quality First Time.

Performs other duties and tasks as defined.

Who you are

A Bachelor’s degree in a relevant discipline is required, along with at least eight years of progressive work experience that demonstrates increasing levels of responsibility.

Alternatively, a Master’s degree in a relevant discipline is preferred, accompanied by six or more years of progressive experience. A Ph.D. in a relevant discipline is also preferred and should be supported by at least four years of progressive work experience, with leadership experience similarly preferred.

Experience in a leadership capacity is preferred.

Knowledge, Skills and Abilities

Proven ability to develop and execute validation plans for automated equipment, including FAT, SAT, IQ, OQ, and PQ.

Exceptional knowledge of FDA 21 CFR Part 820, ISO 13485, and risk-based validation practices (e.g., GAMP 5, ASTM E2500), with demonstrated experience in generating compliant validation documentation.

Ability to independently build, mentor, mold and lead team members to achieve departmental targets.

Proven ability to manage activities and resource allocation to a project schedule.

Exercises independent judgment in developing methods, techniques and evaluation criteria for obtaining results.

Proven ability to contribute and interact productively and collaboratively with project teams as a creative, innovative manager.

Relocation benefits are available for this posting.

The expected salary range for this position based on the primary location of California is $109,800 - $203,800 annual. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law.  A discretionary annual bonus may be available based on individual and Company performance.  This position also qualifies for the benefits detailed at the link provided below.

Benefits

GenMark is now a proud member of the Roche Group, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare.  As a global leader in healthcare, Roche Diagnostics offers a broad portfolio of products, tools and services that help in the prevention, diagnosis and management of diseases like HPV, HIV, hepatitis and diabetes as well as other medical conditions, such as fertility and blood coagulation. With the addition of GenMark to the Roche Group, syndromic infectious disease diagnostics is now added to the long list of disease states and conditions that the Roche Group addresses.  GenMark’s ePlex true sample-to-answer system offers unique solutions to address the most significant challenges facing clinical laboratories, while supporting hospital systems to deliver patient-centered, value-based care. ePlex streamlines the diagnostic workflow from physician order entry to the final test report and is the true sample-to-answer solution designed to improve patient care, reduce costs, and increase lab efficiency. GenMark is headquartered in Carlsbad, California.

GenMark is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.

If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.