Validation Engineer, Automated Equipment at Invitae (Greater Boulder Area, CO)
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 Validation Engineer, Automated Equipment, you will play a critical role in supporting and expanding the company’s manufacturing and quality control processes while maintaining cGMP compliance. You enjoy working in a dynamic environment with a high degree of flexibility, have experience with development and validation of automated equipment and systems in a regulated facility, and a passion to work as a leader within multi-functional teams.Responsibilities:
Job performance will involve a variety of activities including:
- Assist in development of specifications as they relate to the equipment system and intended use.
- Participation and review of applicable acceptance testing.
- Writing and executing test validation protocols and associated documents.
- Maintaining procedures, policies, documents for validation activities.
- Review, understanding, and compliance with Invitae 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 Invitae for purposes of personalized molecular pathology.
- Minimum 5 years of validation experience within a regulated industry; in vitro diagnostics, medical device, or biotech preferred.
- Bachelor’s degree in an engineering or science field.
- Installation of MES software systems into various manufacturing environments.
- Additional experience with computer systems and/or test method validation is preferred, but not required.
- Use of Microsoft Office products, Smartsheet, and similar systems.
- Drive and determination
- 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.