A rapidly growing Medical Device client in south Orange County is looking to identify and hire a Chemical Process Engineer on a direct hire basis. Reporting to the Senior Director of LAL Manufacturing, the Chemical Engineer will support the company’s Light Adjustable Lens (LAL) manufacturing process development and will be responsible for the LAL chemistry manufacturing / test equipment design & validation, as well as the production scale-up including comprehensive documentation of these activities. A successful Chemical Engineer will continually strive to assess and improve upon the present state of operational consistency, efficiency, and quality throughout the product lifecycle. The position will interface extensively with RD&E, and QA.
The Chemical Process Engineer will be responsible for, but not limited to:
- Carefully observing the LAL chemistry manufacturing process to gain a deep fundamental understanding of discrete operations and associated equipment.
- Defining and solving a wide range of challenges inherent to the manufacturing and testing of silicone intraocular lenses and formulations.
- Supporting process improvement initiatives to enhance production efficiency, as well as ensuring business continuity and regulatory compliance.
- Efficiently evaluating the current manufacturing processes for material preparation and testing, and devising strategies for scalability, high throughput testing, and production.
- Implementing and evaluating improvements related to processing tooling/fixture design, processing equipment, and inspecting instruments & methods.
- Designing, drafting, executing Validation Protocols (IQ/OQ/PQ) and writing Validation Reports.
- Performing Gauge R&R studies for the manufacturing process and inspecting/testing equipment.
- Working methodically and collaboratively to identify process failure modes; propose and implement solutions to address root cause.
- Working with external vendors to clearly communicate requirements, specifications, and tolerances for custom parts and off-the-shelf equipment.
- Effectively communicating process, equipment, and test method changes across functional groups by updating manufacturing work instructions, operating procedures, and drawings within the quality system.
- Evaluating downstream or upstream impacts of process/design changes.
- Using a variety of optical/mechanical inspection & test instruments to measure process outputs.
- Routinely procuring, installing, and validating process and inspection/test equipment according to established protocols as required for production ramp-up.
- Implementing a Laboratory Information Management System for efficient testing, data collection, and tends.
- Providing support for QAD and bridging gaps for documentation between Purchasing, Quality, Chemistry, and Manufacturing Departments.
- Identifying opportunities to enhance production efficiency & quality through process automation.
- BS in Chemical Engineering or equivalent with a minimum of 3 or more years of experience.
- A demonstrable track record of success in achieving and maintaining high quality standards.
- Functional understanding of the full design cycle from concept to product release.
- Ability to balance multiple projects with a high degree of urgency.
- Flexibility to accommodate and respond to abrupt changes in priorities.
- Excellent communication skills in both verbal and written formats, as well as excellent listening and problem-solving skills.
- Ability to interface effectively with all levels and functions within the company.
- Prior experience with design or manufacturing and testing of silicones preferred.
- Experience with a wipe film evaporation technique preferred.
- Minimum of 3 years of experience with GMP & GDP in the medical device or pharmaceutical industries preferred.
- Experience with mechanical design using CAD software (SolidWorks preferred).