Senior Process Development Engineer (ADX-25-21)
Senior Process Development Engineer (ADX-25-21)
COMPANY SUMMARY:
In October 2020, Invitae Corporation (NYSE: NVTA) combined with ArcherDX, a genomic analysis company specializing in cancer diagnostics and monitoring, to create a leading comprehensive medical and cancer genetics company. As a combined company, Invitae, is bringing world-class genetic testing and diagnostics into mainstream medicine to improve healthcare for billions of people. Our goal is to aggregate the world’s genetic tests into a single service with higher quality and accuracy, faster turnaround time and actionable results. Learn more at invitae.com and archerdx.com.
POSITION SUMMARY:
We are looking for a Process Development Engineer to join the Operations Engineering team at ArcherDX/Invitae. This team is responsible for transferring, developing and improving process in the regulated In Vitro Device operation. Our process must be capable of producing a high volume and high mix of customized assays used in oncology, immunology, and constitutional genomics. The process development engineer will be responsible for designing, implementing, and improving manufacturing process and will work closely with R&D, Quality, and Operations to support new and existing products.
RESPONSIBILITIES:
- Analyze and improve current production processes
- Develop, test, and implement new manufacturing processes
- Provide expertise in automation, design of processes and scale-up
- Generate documentation required to create and improve automated and manual process
- Help adapt robotic equipment to support the automation of the production processes
- Communicate effectively with all levels of R&D, production and management
- Coordinate with production and manufacturing for the evaluation and implementation of new equipment and processes
EXPERIENCE:
- 5-8 years of experience in production support/sustaining and/or process development, design, scale-up, process improvement and validation
- Experience designing, programming and delivering applications
- Experience working in a GXP environment with emphasis on GCP, GLP, and GMP
- Experience in documenting and analyzing experimental data
- Experience in the biotech or pharmaceutical industries (is a plus)
- Robotic equipment for liquid handling experience (is a plus)
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
- Strong communication and presentation skills
- Driven to perform, a self-starter
- Self-directed: needs little explicit direction
- Able to organize, prioritize, and delegate tasks to efficiently move projects forward
EDUCATION:
- B.S. or M.S. in Chemical Engineering, Biochemical Engineering, Bioengineering, Biomedical Engineering, Manufacturing Engineering