Invitae is dedicated to bringing comprehensive genetic information into mainstream medicine to improve healthcare for billions of people. Our team is driven to make a difference for the patients we serve! We are leading the transformation of the genetics industry by making genetic testing affordable and accessible for everyone to guide health decisions across all stages of life.Position summary:
As the Senior Validation Engineer, you will play a critical role in supporting and growing the company’s manufacturing and quality control processes while maintaining GMP compliance. You thrive in a dynamic environment with high expectations and rapid change, have solid experience developing and validating manufacturing processes in a regulated environment, and are comfortable in a lead role with multi-functional teams.
This role is onsite at our Boulder, CO location.Responsibilities:
- Assist in development of requirements and specifications as they relate to the process and intended use.
- Participation and review of applicable acceptance testing.
- Writing and executing validation protocols and associated documents.
- Maintaining procedures, policies, documents for validation activities.
- Assistance in development activities leading up to validation to include FMEAs, Process Flow Maps, and technical transfer activities.
- Review, understanding, and compliance with company HIPAA Security policies and procedures.
- Safeguarding the privacy and security of protected health information and European Union personal data.
- Processing and handling of European Union personal data only as directed by company for purposes of personalized molecular pathology.
- 8+ years of validation/process engineering experience within a regulated industry; in vitro diagnostics, medical device, or biotech preferred.
- Bachelor’s degree in an engineering or life science subject area.
- Leading projects with firm understanding of the relationship between the need-by date and the requirements for completion.
- Additional experience with automation and equipment is preferred, but not required.
- Use of Microsoft Office products, Smartsheet, and similar systems.
- Drive and determination
- Ability to work in a fast paced and dynamic environment
- Ability to participate with others as a member of the team to ensure that demanding and difficult projects are handled smoothly and cooperatively to enhance the success of the projects and maintain strong relationships within all parts of the company.
- Strong communication and presentation skills
- Able to organize, prioritize, and delegate tasks to efficiently move projects forward.
In Colorado, our competitive compensation package includes a base salary starting from $102,200. In determining the final salary offered we will evaluate a specific candidate geographic location, education, skills and experience.
Invitae offers a competitive total rewards package, which includes healthcare coverage, 401k, and a broad range of other benefits, outlined below:
- Health, dental, vision, short- and long-term disability, and basic life insurance coverage
- Paid time off, holiday pay, parental leave, and other health and wellness supports
At Invitae, we value diversity and provide equal employment opportunities (EEO) to all employees and applicants without regard to race, color, religion, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status. We will consider for employment qualified applicants with criminal histories in a manner consistent with the requirements of the San Francisco Fair Chance Ordinance.