Description / Scope / Mission
The purpose of this position is to identify, reduce/eliminate, and maintain microbial risk within the plant to an acceptable level, in line with the customer expectations and the regulatory requirements (FDA cGMP, BRCGS Consumer Products standard, ISO9001 standard).
The scope of this position pertains to any/all areas within the plant, as well as those that may originate outside the plant (i.e., via suppliers), that add microbial risk to the manufacturing processes, and ultimately, the business.
 
 
Key Responsibilities/ Accountabilities

1. Develop and keep up to date the Hygiene Program for the plant, according to any applicable regulatory requirements, ensuring its effective implementation to minimize the microbial risks.
2. Support the development and update of Preventative Maintenance plans for manufacturing equipment, based on Microbial Risk Assessments.
3. Coordinate the development and update of effective and efficient Cleaning & Sanitizing processes and procedures for manufacturing equipment, supporting their execution.
4. Coordinate the validation of Cleaning & Sanitizing procedures.
5. Lead the Environmental Monitoring program to ensure the respective areas of the plant maintain allowable cleanliness.
6. Train/mentor manufacturing staff on the correct procedures for cleaning & sanitizing, to ensure consistent execution. Conduct microbial awareness and aseptic technique training to required occupations, to drive awareness/accountability on the possibility of micro contamination.
7. Conduct periodic 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 (as needed) to reduce microbial risk.
9. Actively collaborate in the Out-of-Specification (OOS) Investigations as they pertain to microbial data, contributing to Root Cause Analysis and Corrective Action Plan development.

1. Provide support for external audits (customer, regulatory).
2. Work with customers to implement Cleaning & Sanitizing procedures, to ensure both parties are in alignment.
3. Support he identification of 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.

• BS degree in Microbiology preferred, but other related life sciences may be acceptable based on review/experience.
• At least 5 years of experience in manufacturing; preferably in chemical (regulated products: pharma, OTC, cosmetics, medical devices, etc.) 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, BRCGS (or other GFSI scheme), Good Laboratory Practices (GLPs), current Good Manufacturing Practices (cGMP), and USP standards/requirements preferred.

• None. However, candidates with Lean Manufacturing and Six Sigma are preferred.

• Stand; use hands to handle or touch; stoop, kneel, crouch or crawl; smell up to 1/3 of the time.
• Walk and sit 1/3 to 2/3 of the time.
• Talk or hear 2/3 and more of the time.
• Up to 10 pounds to be lifted or force to be exerted up to 1/3 of the time.
• Up to 25 pounds to be lifted or force to be exerted up to 1/3 of the time.

• Color vision (ability to identify and distinguish colors).
• Ability to adjust focus (ability to adjust the eye to bring an object into sharp focus).

• Computer to be used 1/3 to 2/3 of the time.

• Exposure to wet, humid conditions (non-weather); work near moving mechanical parts; exposure to fumes or airborne particles; exposure to toxic or caustic chemicals; and work/job related travel up to 1/3 of the time.
• Exposure to moderate noise.
• Safety glasses required.
• Occasional use of lab coat.