Senior Validation Engineer, Computer Systems (ADX-312-20)

POSITION SUMMARY:

ArcherDX (Invitae) is a growing, innovative company developing assays and software for next generation sequencing (NGS) with applications in research and in vitro diagnostics. The Senior Validation Engineer will have a critical role in supporting and expanding the company’s manufacturing and quality control processes while maintaining GMP compliance. Key attributes of the successful applicant include the ability to work in a dynamic environment with high expectations and rapid change, experience with development and validation of computer systems in a regulated facility, and willingness to work as a lead within cross-functional teams.

RESPONSIBILITIES:

Job performance will involve a variety of activities including:

• Assist in development of specifications as they relate to the computer 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 ArcherDX 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 ArcherDX for purposes of personalized molecular pathology.

EXPERIENCE:

• Minimum 8 years of validation experience within a regulated industry; in vitro diagnostics, medical device, or biotech preferred.
• Installation of software systems into various manufacturing and supporting environments.
• Additional experience with automation and equipment is preferred, but not required.
• Use of Microsoft Office products, Smartsheet, and similar systems.

KEY ATTRIBUTES:

• 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
• Self-starter
  • Driven to perform
  • Self-directed: needs little explicit direction
  • Able to organize, prioritize, and delegate tasks to efficiently move projects forward.

EDUCATION:

• Bachelor’s degree in an engineering, computer systems, or science discipline