Process Engineer

Job Summary

In this role, you will organize, coordinate, or perform modifications, validations, and enhancements of processes and equipment to ensure safety, maximum yields, quality, cost effectiveness and throughput of our processes. This role will primarily focus on the processes surrounding mixing and extrusion of rubber.

Essential Duties and Responsibilities

• Lead assigned process improvement projects.
• Plan, schedule, or perform projects within the approved time schedules and budgets.
• Guide, coordinate, or perform modifications, improvements or validations of existing or new formulations/products, processes and equipment.
• Ensure that all projects and activities are in compliance with local, regional and best practice requirements on HSE and meet other applicable authority requirements.
• Follow all internal change control procedures strictly, including adequate risk assessment / FMEA.
• Support product transfer projects between plants from a process standpoint as assigned.
• Support & manage process or technology transfer projects between plants from a process standpoint as assigned.
• Support new and experimental development activities.
• Support projects and initiatives stemming from the Global Process Engineering team.
• Support/lead Operations Excellence lean and continuous improvement activities.
• Review procedures to ensure they reflect the most effective means and contain the most current and correct information.
• Maintain Process engineering records and documents as required.
• Gather and evaluate in-process control data (CPP graphs, rheological data, etc.) to support process improvements and ensure process quality.
• Initiate, support, execute CAPA and other quality initiatives.
• Ensure compliance with cGMPs, FDA and other regulations as necessary.
• Prepare reports as required on a routine basis or on demand within established deadlines.
• Safeguard confidential information.
• Maintain effective team member relations.
• Perform other duties as assigned based on business needs.
• Conform with and abide by all regulations, policies, work procedures, instructions and all safety rules.

Education

Bachelor's Degree in Engineering required.

Work Experience

Minimum 3 years experience or similar job experience within the manufacturing industry. Ability to assert technical solutions and standards. Self-motivated, results and solution-oriented personality. Must have excellent written and verbal skills. Excellent interpersonal skills: good team player and individual contributor.

Preferred Knowledge, Skills and Abilities

• Good knowledge of LEAN and 6 sigma manufacturing principles: minimum 6 sigma green belt.
• Working knowledge of SPC and Minitab software.
• Knowledge of cGMP manufacturing, preferably pharmaceutical manufacturing.
• Ability to authorize/revise SOIs, SOPs and validation documents.
• Aware of all relevant SOPs as per Company policy related to the position.
• Comply with the company's safety policy at all times.
• Comply with the company's quality policy at all times.

License and Certifications

Manufacturing Six Sigma Green Belt Certification preferred.

Travel Requirements

5%: Up to 13 business days per year.