Plant Hygiene Specialist
Our global manufacturing client in Manitowoc is growing and has a fantastic opportunity for a Plant Hygiene Specialist to identify, reduce/eliminate, and maintain microbial risk within the plant to an acceptable level. They offer full benefits and a positive work culture. This is a direct-hire role.
· At least 5 years of experience in manufacturing; preferably in chemical or food industries.
· At least 2 years of experience relating to cleaning and sanitizing of manufacturing equipment; knowledgeable in clean/sanitary design, as well as the principles of cleaning and sanitizing.
· Experience with ISO 9001, Good Laboratory Practices (GLPs), current Good Manufacturing Practices (cGMP), and USP standards/requirements preferred.
· BS degree in Microbiology preferred, but other related life sciences may be acceptable based on review/experience.
· Lean Manufacturing and Six Sigma Preferred
1. Preventative Maintenance plans for manufacturing equipment
2. Develop effective and efficient cleaning and sanitizing procedures for manufacturing equipment.
3. Work closely with the Validation department to validate Cleaning & Sanitizing procedures.
4. Authorize and revise Standard Operating Procedures (SOPs) for cleaning and sanitizing.
5. Train/mentor manufacturing staff on the correct procedures for cleaning & sanitizing.
6. Supervise, inspect, and collect samples during Complete Tear Downs (CTDs) for C&S Validations, PMs, and OOS investigations.
7. Conduct daily, weekly, monthly audits of the manufacturing areas to identify microbial risk areas; analyze audit data and prepare corrective action plans to reduce microbial risk.
8. Maintain, audit, and update the Master Cleaning Schedule of all departments
9. Environmental Monitoring
10. Lead Out-of-Specification (OOS) Investigations (per procedure) Maintain and track OOS Investigations through the OOS log, and report results to the QA & Compliance Manager.
11. Research microbial species and prepare associated risk assessments.
12. Based on the OOS Investigation, if the material is determined to be truly OOS, enter a Non-Conformance in Unipoint.
13. Utilize Root Cause Analysis to determine the true reason for microbial failures; develop effective action plans to address Root Cause.
14. Provide support for external audits (customer, regulatory).
15. Act as a liaison and knowledge reference between Quality and various departments, to ensure procedures are followed, to minimize microbial risk throughout the business.
MARGINAL JOB DUTIES:
1. Obtain quotes related to improving cleaning and sanitizing processes
2. Work with customers to resolve/implement microbial specifications, microbial test methods, cleaning and sanitizing procedures.
3. Work with Validation and the QA & Compliance Manager to identify critical control points (CPPs) and implement effective sampling plans for routine production.
4. Assist with assigned sections of Annual Product Reviews.
5. Conduct Document Reviews, as assigned.
6. Perform other duties as required/requested by the QA & Compliance Manager.