Benefits:

Dental insurance

Health insurance

Stock options plan

Vision insurance

Job Summary:

We are seeking a driven and versatile Sr. Process Engineer to provide technical leadership in new product introduction, process development, and sustaining activities. The ideal candidate is customer-focused and motivated by the opportunity to work on diverse, cutting-edge technologies in the life sciences and in vitro diagnostics spaces. This role will lead teams and collaborate cross-functionally with customers, suppliers, R&D, Quality, and Operations to design, implement, and improve manufacturing processes in compliance with product and quality system requirements.

Key Responsibilities:

Troubleshoot production issues related to yield, quality, and throughput.

Resolve process and equipment challenges and implement validated solutions.

Leads teams to develop and optimize manufacturing processes for new and existing products in partnership with customers, suppliers, R&D, Manufacturing, and Quality.

Design and execute controlled experiments (including DOE) to define and optimize processes, address yield and quality issues, and drive implementation in an ISO 13485 manufacturing environment to meet Operation’s and our customers’ goals.

Analyze test results, prepare technical reports, and implement process improvements.

Define technical requirements and write procedures. Define and drive execution of validation plans, protocols, and reports.

Manage tech transfer activities in compliance with ISO and cGMP standards.

Required Skills & Qualifications:

B.S./M.S./PhD in Chemical Engineering, Biochemical Engineering, Bioengineering, or Biotechnical Engineering with at least 5 years of relevant experience.

At least 2 years of experience working in a cGMP environment desired.

Work experience in the biotech, diagnostic, pharmaceutical, or medical device industry is required.

High level problem solving and reasoning skills required.

Experience developing filling and sealing processes for chemical, biochemical, or biological products highly preferred.

Experience with manufacturing and liquid handling automation is a plus.

Experience applying statistics, Statistical Process Control, and DOE techniques is a plus.

High level computer skills are required. Intermediate level programming knowledge is desired.

Experience with product development processes, design controls, and project management is a plus.

Good interdepartmental communication skills and documentation skills are required.

Demonstrated ability to accomplish goals while working across departments is required.

Physical Requirements:

Ability to lift up to 30 pounds.

Equal Opportunity Employer

We are an equal opportunity employer and value diversity at our company. We are committed to providing equal employment opportunities without regard to race, color, religion, gender, sexual orientation, national origin, age, disability, or any other protected characteristic as established by law.