Process Engineer

Schedule:

8:00 AM – 5:00 PM, Monday–Friday (occasional 6:00 AM start), some overtime as needed.

* This is a temp-to-possible-hire opportunity.

• Candidates must have experience working in a pharmaceutical, chemical, or other highly regulated cGMP manufacturing environment.
• This is a temp-to-possible-hire opportunity.
• Strong preference for candidates with experience manufacturing pharmaceutical solutions, solvents, or similar products.
• Position will support capital projects involving both manufacturing equipment (hardware) and control systems/software.
• Responsible for maintaining and improving production line performance, equipment uptime, and operational efficiency.
• Will partner closely with Safety and Quality teams to identify and resolve manufacturing, compliance, and process-related challenges.
• Expected to troubleshoot equipment downtime issues and drive continuous improvement initiatives to keep production running efficiently.
• Bachelor's degree in Engineering is required.
• Seeking candidates with 5–8 years of Process Engineering experience, ideally gained entirely within cGMP-regulated manufacturing environments.
• Strong communication and presentation skills are essential, as this individual will develop business cases, interact with vendors, and communicate recommendations to cross-functional stakeholders.
• Looking for a hands‑on engineer who can effectively support day‑to‑day manufacturing operations while also contributing to larger capital and process improvement projects.

• Interfaces with Engineering, Maintenance, R&T, and other clients; participates in routine communication between each of these groups and the business.
• Provides timely and effective data analysis, root cause analysis, corrective and preventative action execution in response to process trends, out-of-control data points, or any other issues as they arise with platinum-level customer products.
• Leads multi‑functional process capability improvement, MOC, and validation efforts, including driving continuous improvement projects while providing clear technology direction and operational production support.
• Collaborates with Production Leadership, Procurement, and external vendors to implement/lead business improvement plans.
• Accountable for product quality, safety, non‑conforming product disposition, process throughput, waste minimization, training/skill usage of hourly employees, yield improvement, investigation, and reduction of production variances for identified products/processes.
• Accountable for tracking process reliability, developing corrective action reports and complaint responses, implementing process improvements, and corrective actions.
• Works in conjunction with all plant engineering disciplines, R&T, and customers to support new products and new manufacturing technology platforms in operations.
• Directs contractors and hourly employees to monitor processes, collect data, install equipment, and make process modifications.
• Develops and implements metrics to monitor and improve process safety, performance of equipment, processes, and/or overall product quality trends to reduce process variability.
• May develop, design, and implement capital projects to support plant initiatives.
• Performs other duties as assigned, with or without accommodation.

• Bachelor's Degree in Chemical Engineering or a related field required.
• Knowledge of basic problem-solving tools (DMAIC) and lean manufacturing concepts (Kanban, Kaizen, 5S) required.

• Minimum of five (5) years of related experience required.
• Minimum of two (2) years of experience working in a chemical manufacturing environment required.

• Knowledge of OSHA, NFPA, Haz Woper, and other governmental regulatory requirements (e.g., 21 CFR Part 820, cGMP, ISO, FDA, etc.).
• General knowledge of chemistry and high‑purity chemical processing/engineering and microelectronic applications required.
• Demonstrated complex problem‑solving expertise and experience.
• Demonstrated application and implementation of SPC tools.
• Working knowledge and experience in:
• Distillation and separation purification technologies
• Chemical synthesis unit…