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.
The Senior Director Engineering will be responsible for establishing, leading, and managing the operations engineering team for regulated products. This includes leading engineering teams that support daily operations of the facility, specifically process and project engineering, process validation teams, packaging and labeling, and metrology. The Engineering Senior Director is also responsible for the productivity and development of the employees with the purpose of ensuring that reliable and compliant equipment and systems are used in the manufacturing process. This position will ensure that the Invitae provides its internal and external customers with industry leading and innovative products and services that meet or exceed established requirements including US FDA regulations, GMP (good manufacturing practice) and ISO 13485:2016.
- Demonstrate Safety leadership, Drive the culture of safety first - quality always
- Strong partnership and influence with Operations, QA/QC, Regulatory, Supply Chain, Finance, and other leadership areas
- Lead and support site engagement
- Provide technical, business and people leadership support to the engineering staff, including setting team goals, ensuring appropriate training and qualification, completing performance reviews and establishing development plans
- Manage staffing including recruiting, resource planning, and succession planning
- Identify training requirements and develop the skill-set within the engineering group to support existing and new technologies
- Support manufacturing organization with technical resources to resolve equipment and process issues and collaborate with other department leaders to resolve issues and oversee day to day operational aspects of the engineering function
- Strategically develop a future state Site Master Plan, maximizing the use of current Invitae assets while developing plans future growth
- Develop and execute an Engineering Roadmap that successfully allows for all business commitments to be met while simultaneously optimizes business processes for efficiency and effectiveness and standardizes engineering operations.
- Identify, track, and report key indicators of functional performance
- Play a leading role in ensuring that team members and all Engineering procedures and processes are in compliance with applicable Regulations, Good Engineering Standards, site Quality Standards and Engineering Standards and other relevant specific corporate directives
- Develop, track and report out KPIs that drive continuous improvement in the performance of services provided, including downtime, WO response time and closure, PM’s, and customer satisfaction
- Collaborate with project management to ensure effective resource utilization, planning, and execution of projects that are in alignment with business objectives.
- Responsible for site development strategy and managing the capital investment plan and budget
- Manage and develop the reliability programs and equipment strategies to minimize down time for all critical pieces of equipment and thereby minimize product write offs due to equipment malfunction or poor process control
- Manage the development, delivery, and execution of the site validation program including installation qualification, operational qualification, and equipment validation leading to successful cGMP process validations.
- Ensure strict adherence to the maintenance schedules generated and carry out a program review on a regular basis
- Manage system to minimize disruptions to production and product supply
- Identify and diagnose opportunities for improvement that impact safety, environment, labor productivity, machine/manufacturing efficiency, cost reduction, product quality and other key performance objectives as defined by the business and work in concert with cross functional department heads to define and execute improvement plans.
- Implement project management procedures and manage limited resources to deliver projects on time and on budget
- Minimum of ten (10) years in a regulated (ISO 13485, 21CFR820) healthcare industry (IVD, Pharma, Medical Device) with direct experience in a cGMP environment; Knowledge of principles and guidelines of CFR 9 and GMP guidelines.
- Minimum of seven (7) years of experience managing/directing people and projects;
- Experience in specifying, installing, validating, technology transfer, and optimizing equipment;
- History of successful performance in a fast-paced environment with a proven ability to make important decisions independently with limited key information, often under pressure and tight deadlines
- Experience managing complex cross-functional initiatives while instilling teamwork within the department and demonstrating key interpersonal skills
- Demonstrated ability to communicate verbally and in writing to various audiences, particularly one-on-one coaching and feedback with direct reports and peers
- A Bachelors degree in Engineer is required
In Colorado, our competitive compensation package includes a base salary starting from $190,000. In determining the final salary offered we will evaluate a specific candidate 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.