Job Title: Process Engineer
Department: Materials
Status: Full Time – Non-Exempt
Reporting To: Business Unit Manager

EDUCATION, QUALIFICATIONS AND EXPERIENCE:

• Bachelor of Science degree in Chemical Engineering or related technical degree with 2+ years of experience relevant to this role.
• Previous experience working in a manufacturing environment with a quality management system, preferably in compliance with ISO 13485 and/or 21 CFR Part 820
• Strong analytical/problem-solving skills with demonstrated ability to collect, summarize, and report technical information
• Proficient in application of various statistical techniques and analysis preferred (Minitab a plus)
• Experience analytical equipment such as FT-IR, HPLC, and NMR preferred
• Experience with LEAN/Sigma-Six manufacturing preferred
• Self-starter and motivated individual who works well both independently and with a team
• Detail-oriented, highly organized individual who can handle multiple projects simultaneously
• Excellent oral and written communication skills
• Proficient in the use of Microsoft Office, Word, and Excel.

POSITION PURPOSE:

The Process Engineer provides operations support to meet project goals and timelines for chemical manufacturing with varying technical responsibility. This includes developing, maintaining, optimizing, and improving manufacturing processes and test methods to keep up with the needs of the business. All work will be required to stay in compliance with applicable regulations and quality standards in a fast-paced environment.
This position requires a quick learner, who is hands on, and can utilize critical thinking to solve technical problems. Working both independently and collaborating cross-functionally is critical. The selected individual must be able to promote a positive work ethic and demonstrate commitment quality, innovation, and continuous improvement.

RESPONSIBILITIES:

• Play a key role in designing and developing chemical manufacturing processes for large scale production of various solutions within an FDA compliant design control system.
• Create and validate new test methods.
• Perform appropriate equipment qualifications (DQ/IQ/OQ/PQ).
• Produce the appropriate design control documentation to fulfill the needs for product commercialization.
• Establish technical documentation for internal test plans & protocols for experiment/study execution.
• Communicate and present results to project leaders and other team members clearly and concisely.
• Write and review manufacturing work instructions and applicable forms
• Revise existing documents, processes, and/or methods for corrections and improvements.
• Initiate and process document change orders.
• Troubleshoot issues in manufacturing.
• Support and/or perform other duties as required.