POSITION SUMMARYThis position will be responsible for providing process engineering support for our all aspects of the biochemical manufacturing process which includes formulation, testing, reagent beads, lyophilization and the use of chemistry within the diagnostic equipment itself. The ideal candidate will use industry best practices and their expertise to measure, analyze and specify requirements that lead to best-in-class quality products and design for manufacturability. We are looking for a highly motivated candidate, who can work cross-functionally.
IMPACT AND ORGANIZATIONAL CONTRIBUTION- Lead projects relating to the development and optimization of production processes, including plant design, process equipment/workflows, and material handling.
- Evaluate existing manufacturing processes and for improvements in capacity, efficiency, and product quality in alignment with business needs.
- Improve testing methods and quality control measures for reagents, incoming materials, standards, and controls.
- Develop user requirements for new capital equipment, survey potential equipment suppliers, submit RFQs, evaluate proposals from suppliers and provide recommendation for purchase.
- Develop and execute test protocols and reports to validate new or modified processes.
- Strong ability to investigate root cause of production issues impacting product quality or yield, support implementation of improvements, countermeasures, and preventative action.
- Identify sources of variation (procedure, process, equipment, people) within the manufacturing process and design solutions
- Recognizes need for and embraces concept of continuous improvement. Creates new ideas and recommendations based on engineering data, facts, and observations.
- Collects process data and performs trending and statistical evaluation to monitor process performance to understand stability and areas for improvement.
- Effectively partners with and motivates enabling support teams to improve operations for the advancement of the whole site and company.
- Maintain quality control and safety standards.
- Actively contribute to meeting business objectives around compliance, cost savings, and potentially capital spend requirements.
- Assists in completing validation activities as required.
- Assists in non-conformance and CAPA investigations.
EDUCATION AND EXPERIENCE- BS in Chemical, Material, Industrial or Mechanical Engineering with 6+ years of experience.
- Food and Drug Administration, USDA and/or work in a regulated manufacturing environment, preferably in the diagnostics or biodevice industry, is required.
- Proven experience in the application of engineering principles to the design and improvement of manufacturing processes.
- Experience in working with contract manufacturing organizations and third-party suppliers.
- Experience with lyophilization and test methods validation is preferred.
- Experience with Operational Excellence tools such as DMAIC, 5 why's, Fishbones, FMEA, etc.
- Green belt or Black belt certification is a plus.
- Demonstrated ability to interact effectively with colleagues and management across departmental boundaries.
- Candidate must possess flexibility and agility to respond to constantly changing conditions and priorities.
- Proficient computer skills such as Excel, Word, MS Visio, JMP, Minitab, or similar software
- Must be willing to quickly learn and become proficient in common systems used to manage the business - to include production schedule, quality deviations, ERP system, and change control.
Work Environment: Colleague must work onsite, be able to lift at least 50 pounds, and work near moving mechanical parts with moderate noise level where the use of hearing protection is optional and eye protection is required.
The following base pay range reflects the anticipated base pay for this position if a selected candidate were to be located in
[ California] Base pay may vary based on location and other factors.
Base Pay Range: $80,000 - $122,000
[This position is eligible for short-term incentive compensation.] We offer a competitive and comprehensive benefits package, which includes healthcare, dental coverage, and retirement savings benefits along with paid holidays, vacation and disability insurance.
Full time
Regular
Colleague
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