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Lead Sanitary Process Engineer
2 months ago
Company Overview:
Agile Enterprise Solutions is a dynamic organization dedicated to innovation and excellence in the healthcare and professional markets. We specialize in the development and distribution of high-quality products that promote health and safety.
Position Summary:
We are seeking a highly skilled Senior Sanitary Process Engineer to join our team. The ideal candidate will possess a Bachelor's degree in Mechanical Engineering, Chemical Engineering, Chemistry, or a related scientific discipline.
Experience Requirements:
The successful applicant will have eight to ten years of relevant experience in manufacturing, engineering, quality assurance, or process cleaning. Of this experience, a minimum of five years must be in chemical processing, with at least three years as a subject matter expert in process cleaning within a GMP environment.
Key Responsibilities:
1. Establish and communicate standardized procedures for effective cleaning and sanitization of chemical batching processes and product contact surfaces, ensuring compliance with GMP standards across all production sites.
2. Evaluate and enhance cleaning and sanitization programs in collaboration with manufacturing locations to meet both GMP and company standards.
3. Develop and implement methodologies for validating cleaning processes.
4. Collaborate with engineering teams to establish best practices related to fluid system design and sanitation protocols.
5. Review and improve environmental monitoring programs to mitigate microbiological risks.
6. Work closely with plant leadership on investigations and corrective actions concerning cleaning and sanitization of equipment and processes.
7. Create monitoring and verification programs aimed at continuously enhancing the quality and effectiveness of cleaning initiatives across all manufacturing sites.
8. Conduct risk-based audits to identify and rectify gaps in hygienic controls and sanitation procedures.
9. Act as a liaison with industry trade groups to remain informed about advancements in process cleaning and sanitization.
Qualifications:
All candidate information will be kept confidential in accordance with EEO guidelines.
