Process Engineer (Biochemical)

POSITION SUMMARY

The Process Engineer will be responsible for providing biochemical process engineering support of formulation, testing, reagent beads and the use of chemistry within the diagnostic equipment itself. The ideal candidate will use industry best practices and their expertise in biochemistry 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

• Improve testing methods and quality control measures for reagents, incoming materials, standards and controls.

• Performs reagent and finished product testing as needed. Utilize common analytical methods UV-Vis, FTIR, DSC, TGA, MFI, stress strain, SEM, etc

• Build test finished products as necessary as part of root-cause investigation.

• Investigates root cause of production issues impacting product quality or yield, support implementation of improvement and countermeasures.

• 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 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.

• Update procedures as necessary

EDUCATION AND EXPERIENCE

• BS/MS in Chemistry, Chemical Engineering, Material Engineering and/or Biology with 2+ years of experience in a manufacturing environment.

• Food and Drug Administration, USDA and/or Drug Product Formulation is required.

• Experience with lyophilization and test methods validation is preferred.

• 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: $73,000 - $112,000

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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