Process Engineer

Fagron - Wichita, KS

Full-time - Mid Level

Wichita, KS

1,001-5,000 employees

Merchant Wholesalers, Nondurable Goods

About the position

As a Process Engineer at Fagron Sterile Services, you will play a crucial role in optimizing and enhancing manufacturing processes. Your primary focus will be the engineering liaison developing new processing, ensuring cGMP compliance, and driving efficiency improvements. You will be responsible for analyzing current processes, identifying areas for improvement, and implementing solutions that enhance productivity and quality.

Responsibilities

• Work with Director of Engineering designing, developing, and optimizing manufacturing processes, ensuring compliance with regulatory standards.
• Collaborate with NPD, quality assurance, and production teams to troubleshoot and resolve process-related issues.
• Prepare and maintain comprehensive documentation, including Standard Operating Procedures (SOPs).
• Monitor and analyze process performance data to identify areas for improvement and implement corrective actions.
• Ensure adherence to Good Manufacturing Practices (GMP) and other regulatory requirements.
• Conduct risk assessments and develop mitigation strategies to address potential compliance and quality issues.
• Provide training and support to manufacturing personnel on process operations and GMP compliance.
• Conduct process validation and equipment qualification to maintain product quality and consistency.
• Participate in regulatory inspections and audits, providing documentation and supporting evidence to demonstrate compliance with cGMP regulations.
• Contributor during semi-annual shutdowns.
• Other projects and duties as required.

Requirements

• Bachelor's degree in engineering or commensurate experience.
• Minimum of 3-5 years of experience in pharmaceutical manufacturing or a GMP-regulated environment.
• Strong knowledge of GMP regulations and guidelines.
• Experience with process validation, equipment qualification, and regulatory compliance.
• Proficiency in data analysis.
• Excellent problem-solving and troubleshooting skills.
• Strong written and verbal communication skills.
• Self-motivated and customer centric.
• Experience with Microsoft applications (Outlook, Excel, Word).

Nice-to-haves

• Technical Expertise: Strong understanding of pharmaceutical manufacturing processes, equipment, and regulatory requirements.
• Analytical Skills: Ability to analyze complex data and identify trends to drive process improvements.
• Attention to Detail: Meticulous approach to documentation and adherence to regulatory standards.
• Collaboration: Effective teamwork and communication skills to work with cross-functional teams.
• Adaptability: Ability to manage multiple tasks and adapt to changing priorities in a fast-paced environment.
• Problem-Solving: Proactive approach to identifying and resolving process-related issues.
• Leadership: Capability to train and mentor manufacturing personnel on process operations and GMP compliance.

Benefits

• Competitive salary
• Comprehensive benefits
• Performance package
• Opportunities for personal and professional growth
• Dynamic work environment
• Open and informal organization culture