Sr. Engineering Specialist (ADX-36-21)
Sr. Engineering Specialist (ADX-36-21)
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 an experienced engineering specialist to contribute in a cGMP/ FDA regulated environment. The primary role will support equipment selection, installation, calibration, verification and maintenance. The bulk of activity is performed by external suppliers requiring coordination with our internal quality management system. This position will help to execute, review, update, create and improve current processes, potentially moving some of this supporting activity to in-house. The role will also supplement our engineering teams through support of engineering efforts including but not limited to stability studies, process development, process improvements, CAPA and resolution of product quality issues.
RESPONSIBILITIES:
- Key contributor to the team managing laboratory and manufacturing equipment
- Specify, purchase, install, calibrate and verify a variety of equipment used in a laboratory and manufacturing environment
- Support engineering projects such as stability studies
- Participate in corrective actions (CAPA) helping to determine root cause, corrective and preventive actions.
- Aid in the investigation and resolution of customer complaints.
- Lead process improvement projects, creates process flow maps.
- Creates and updates cGMP/FDA process documentation.
- Evaluate risks, identify alternatives, and plan approaches to resolve critical issues.
- Review, understand, and comply with Invitae HIPPA security policies and procedures.
- Safeguard the privacy and security of protected health information and European Union personal data.
EXPERIENCE:
- 8-10+ years' experience in a regulated industry
- History of successful performance in a fast-paced environment with a proven ability to make important decisions, often under pressure and tight deadlines
- Proficiency using Microsoft Word, Excel, and ability to learn other required computer programs.
KEY ATTRIBUTES:
- Strong proficiency in demonstrating attention to detail and ability to help others grow in this area.
- Strong proficiency at managing day-to-day operational aspects of a project and scope.
- Demonstrates strong verbal, listening and written communication skills, organizational and time management skills, presentation skills and attention to detail.
- Ability to foster and maintain relationships with individuals representing a wide diversity of disciplines and levels of sophistication in a collaborative environment.
- Ability to build consensus and relationships among managers, partners, and employees.
- Deadline and deliverable driven individual with an ability to adapt to unexpected or abnormal results or situations.
- 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.
- Self-starter driven to perform with the ability to organize, prioritize, and delegate tasks to efficiently move projects forward.
- Ability to learn technical information provided in trainings
EDUCATION:
- Bachelor’s degree in a technical field or commensurate experience.