ArcherDX is a growing, innovative company developing assays and software for next generation sequencing (NGS) with applications in research and in vitro diagnostics. The process validation engineer will have a critical role 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 process validations in a regulated facility, familiarity with handling biological materials, and open interactions with co-workers with diverse skill sets and knowledge.

RESPONSIBILITIES:

Job performance will involve a variety of activities including:

• Writes executable manufacturing process qualification/validation protocols
• Understands existing production instructions and processes
• Understands existing instructions and processes for quality control (QC) tests
• Interact with internal and external subject matter experts (SME’s) to efficiently develop documents
• Supports laboratory personnel in executing written protocols
• Assists with data interpretation, and leads preparation of summary reports
• Prepares documents that conform with Archer’s quality management system
• Maintains standards and documentation practices that allow for consistent execution of documents
• Collect input from various company stakeholders to consolidate comments and resolve conflicts
• Completes document control steps for protocols and reports
• Maintains tracking spreadsheets and timelines consistent with project goals
• 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:

• Knowledge of FDA Regulations
• Experience working in a GXP environment with emphasis on GCP, GLP, GPV, and GMP
• Exemplary Verbal and Written Communication Skills
• Proficiency using Microsoft Word, Excel, and PowerPoint
• Experience working in a system of collaborative process validation
• Must be a self-starter and capable of working with minimal oversight

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 with 2+ years of relevant process validation experience in the medical device, biotech, or pharmaceutical industry

This job description is not designed to cover nor contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.