PCM Engineer at ArcherDX
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.
We are looking for a driven and talented Manufacturing Engineer to join the Operations group in Boulder, CO. The Manufacturing group is responsible for making rapid and high-quality assays utilizing our Anchored Multiplex PCR (AMP™) technology for use in oncology, immunology, and constitutional genomics. The PCM Engineer will play a key role in delivering best in class systems and processes for high throughput NGS panel manufacturing, paving the way for the personalized healthcare revolution. The ideal candidate will have prior experience in a cGMP-regulated environment using and administering electronic systems and controls. This role will require cross-functional leadership skills in order to develop and implement manufacturing processes in support of scale-up activities.
- Recommend and implement process improvements to optimize PCM manufacturing for speed, quality, sustainability, and scalability.
- Develop and maintain Key Performance Indicators (KPIs) to facilitate continuous improvement of manufacturing systems and processes.
- Coordinate cross-functionally with all Engineering teams to ensure consistent approached between product lines.
- Actively communicate with key stakeholders to identify challenges and opportunities related to the manufacturing operations.
- Coordinate implementation and lifecycle management products to support the Personal Cancer Monitoring value stream by creating relevant documentation, creating and delivering end user training, and managing user accounts.
- Author/review and define process improvements within the Manufacturing process. Update related documentation such as SOPs, business process documents, and training materials to support continuous improvement activities.
- Maintain material masters, equipment classes, and master recipes for tracking and documenting production activities.
- Provide end-user support to PCM manufacturing operators, logistics specialists, and quality assurance personnel.
- Support system related requests such as data retrieval and customer inquiries.
- Assess and implement changes under approved change control procedures
- Resolve issues to ensure uninterrupted demand fulfillment.
- Support digital transformation roadmap activities for other departments and functional groups as needed.
- Understanding of ERP, QMS, and Process Control
- 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
- Driven to perform
- Self-directed: needs little explicit direction
- Able to organize, prioritize, and delegate tasks to efficiently move projects forward
- Bachelor’s degree in Engineering, or other relevant field of study
- 2+ years experience implementing new processes and monitoring sustaining product lines
- 1+ years experience in Process Development of new product lines
- Experience working in a cGMP environment
- Experience supporting electronic batch record systems
- Working knowledge of MS Office and ERP systems
- Ability to apply basic scientific and regulatory principles to solve system issues
- Experience in the medical device, biotech, or pharmaceutical industries
- Experience implementing and supporting Syncade, PharmaSuite, PAS-X, or similar MES platforms
- Experience implementing interfaces between MES, ERP, and process control systems
In Colorado, our competitive compensation package includes a base salary starting from $69,000 per year. In determining the final salary offered, we will evaluate a specific candidate's 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.