Process Engineer II

Job Title: Process Engineer II

Department: Materials

Status: Full Time – Exempt

Reporting To: Business Unit Manager/Local Business Unit Leader

Purpose:

The Process Engineer II 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.

Education, Qualifications and Experience:

• Bachelor of Science degree in Chemical Engineering or related technical degree with 3+ 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.

Working Conditions and Health & Safety:

• Heated and air-conditioned office environment
• ISO Class 7 cleanroom
• Laboratory
• Employee is required to use appropriate PPE including, but not limited to, nitrile or latex gloves, lab coat, hair bonnet, shoe covers, beard cover, safety glasses, hearing protection, face shield, or respiratory mask while working in a lab or manufacturing space

Harland Medical System’s commitment to ensure employee health and safety is a priority. Personnel engaged in manufacturing shall obtain training required by ISO 13485, FDA 21 CFR part 820, FDA 21 CFR part 210 & 211, and Harland Medical System’s internal procedures, where deemed appropriate per assigned job functions.

Physical Demands:

While performing the duties of this job, the employee is regularly required to sit for prolonged period of time. The employee is frequently required to talk and hear; use hands to handle or feel; and reach with hands and arms above shoulder height and below the waist. Using proper lifting techniques, the employee must be able to lift up to 40 lbs.