Senior Process Engineer
Austin, TX /
Research & Development – Automation & Engineering Services /
Full-time
/ On-site
At Pattern Bioscience, we’re tackling antibiotic resistance, one of the biggest public health challenges of our time. We use machine learning and microfluidics to quickly recognize the bacteria causing an infection and to predict which drugs will cure the infection.
We are looking for a Senior Process Engineer that loves to solve problems and make improvements. As Pattern grows, so does the production process and equipment. You will commission, qualify, and support custom equipment and processes to enable scaling of instrument and consumable production. As a part of supporting process development and compliance with FDA guidelines and our Quality Management System, you will create study plans and oversee testing execution and reporting; On our Automation & Engineering Services team, this role interacts closely with Manufacturing, Hardware Engineering, Assay Research and Development, and outside vendors. Below is a sample of the impacts you can expect to make within your first six months.
Goals
- 90-Day: Double throughput capacity for consumable treatment process
- 90-Day: Qualify consumable treatment and freeze-drying equipment
- 6-Month: Support implementation of the reagent plug pick-n-place automation
- 6-Month: Complete all process qualifications required to support manufacturing of production equivalent devices for clinical study
- 6-Month: Have all equipment preventative maintenance and calibrations documented in the QMS system and current
How You Will Contribute
- Deploy equipment and processes for scaling consumable manufacturing with high consistency
- Execute equipment and process tests to identify and reduce variability in coordination with lab technicians
- Ensure all process instructions are updated/released for current configurations
- Ensure process compliance for design verification and validation
- Manage stakeholder expectations around process development
- Coordinating with production planning to ensure equipment down time for preventive maintenance or qualification testing minimally impacts production
- Partner with Quality to release documents and manage approvals of change requests
- Make recommendations on equipment fixture improvements or programming improvements of equipment controllers
- Create the design control documentation to implement and release the process into the quality management system
We'd Love to Hear from You If You
- Have commissioned, qualified, and validated equipment
- Are an independent and creative problem solver
- Are proficient in process development and qualification
- Utilize communication and organizational skills to manage projects effectively across disciplines, especially CAPA projects with proven effectiveness checks
- Run effective DOEs that result in improved product quality and process efficiency
- Can use SolidWorks to review and update documentation
- Understand and have practical experience with a QMS environment, including design controls, risk assessments, and change controls)
Desired Education and Experience
- Bachelor’s Degree in an engineering discipline
- Experience in an FDA regulated industry (medical device or pharma)
- Experience with automation equipment testing and implementation into production processes a plus
Join us! We're excited for what you can bring to our team. Here are a few things we provide to make sure you have a great experience. Learn more about our team by visiting our website.
Benefits
* Health insurance
* 401k Matching
* Paid Time Off
* The opportunity to make a global impact
To fulfill our mission and build world-changing technology, we’ve put together a diverse, multi-disciplinary top-notch team, a culture of innovation, learning, adaptability, and excellence and environment where people love coming to work.
We value diversity on our teams. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity or expression, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law.
