Senior Process Engineer
- 4878 Ronson Ct, San Diego, CA 92111, USA
NanoComposix is a privately-held R&D, and manufacturing company that develops innovative nanomaterials for research and commercial markets supporting medical devices, and pharmaceuticals. We manufacture hundreds of different variants of metal and metal-oxide core/shell nanocomposites for a wide range of applications including biosensors, medical devices, clinical diagnostics, and optical effects. Our mission is to help our clients bring nano-enabled products to market. We’re passionate about what we do and are looking for smart, energetic, and self-motivated individuals who take pride in their work to join our fun and innovative team in this exciting industry.
Benefits include medical and dental insurance, paid vacation and personal days, retirement plan with company-match, and an annual bonus program with opportunity for stock ownership in this employee-owned business.
The Sr. Process Engineer works cross-functionally with R&D, Manufacturing, and Quality to lead nanoparticle based process development projects from external and internal clients. Technical and project management aptitude is required, including experience with process optimization, scale up, tech transfer, design control, process validation and GMP manufacturing.
Principal Duties and Responsibilities
- Lead nanomaterial process development from R&D through GMP manufacturing
- SME for new product introductions, manufacturing and production process development, improvement, and sustaining efforts
- Independently and collaboratively design and execute controlled experiments and projects to develop/optimize processes, address yield and quality issues, drive implementation of solutions in controlled manufacturing and production environment
- Batch Record, SOP development and training
- Validation Protocol development through execution and reporting
- Equipment evaluation, selection, procurement and qualification
- Collaborates with other engineers, scientists, product managers, and staff to review the projects design, manufacturing, and test documentation; ensures that program or contract quality requirements are met
- Identifies root causes of problems in the manufacturing and production process; recommends and/or implements corrective measures.
- Creates and manages timelines associated with process development projects
- Leads internal project meetings to ensure adherence to timelines and resolve technical and scheduling risks
- Communicates regularly with clients in regard to timelines, updates and risks
- B.Sc. in engineering or science field
- 5-7 years of experience as a Process Engineering or similar role
- At least five years of experience in a highly regulated field, including biotech, pharma, or medical device
- Experience in production support, process development, and project management skills
- Experience with purification techniques is a plus
- Experience in aseptic processing is a plus
Knowledge / Skills
- Strong analytical and problem-solving skills
- Laboratory skills
- Excellent verbal and written communication skills
- Extensive knowledge of or the ability to quickly learn manufacturing and production processes
- Proficient with Microsoft Office Suite (including Visio and Project), laboratory analytical and statistical software, and other related software
Human Resources Requirements
- Must be able to life up to fifteen pounds at times
- Prolonged periods of sitting at a desk, working on a computer
- Prolonged periods of standing in a laboratory environment
Qualified candidates should submit a resume and cover letter. The cover letter should include information on how your previous experience relates to the job requirements and your availability. Specific examples are of interest. You will not be considered without a cover letter.
Candidates must be eligible to work in the United States.
All your information will be kept confidential according to EEO guidelines.