Cleaning Validation Engineer
JOB PURPOSE:
This includes designing, planning, and executing cleaning activities (including Cleaning Verification and Validation activities) for Over the Counter (O.T.C.) Drugs in accordance with Food & Drug Administration (FDA) regulatory and Mary Kay guidelines.
Independently plan, perform and/or coordinate cleaning activities to ensure timely completion. Remain current with industry and regulatory agency trends. Provide technical leadership for deviation investigations related to residual product/detergent and microbial contamination issues. Analyze data and provide recommendations for improvements in cleaning/manufacturing process, and equipment Clean In Place (CIP). Prepare protocols and other technical documents, and participate in the interpretation of data, collaborating with other departments. Other responsibilities as directed
ESSENTIAL DUTIES AND RESPONSIBILITIES:
1. Core duties and responsibilities include but are not limited to:
• The position involves cleaning validation monitoring, cleaning cycle development and cleaning validation in a cGMP facility.
• Must be able to analyze data, determine results and present conclusions and recommendations ensuring that projects are implemented in accordance with the agreed scope timelines, policies and procedures, generate and resolve protocol discrepancies or deviations, review GxP deliverables including specifications, drawings, procedural documents, master plans, and validation documentation and train operations staff on protocols, procedures and technical details related to systems or processes.
• Generate and resolve protocol discrepancies or deviations
• Generate reference documents and cleaning Work Instructions based on the cleaning cycles.
• Develop cleaning procedures that minimize cycle time, water, chemicals, and unnecessary action.
• Write technical cleaning evaluations as requested, including calculations such as maximum allowable residue carryover from product to product, and deviations with root cause and impact assessment.
• May perform other cleaning and sanitation validation related duties as assigned
2. Works with business partners to establish procedures and recipes during the new product launch process. Creates design of experiment to test solutions. Identifies risk and elevates during the Design for Manufacturing (DFM) process. Involves key stakeholders to ensure solutions are industrially feasible.
3. Interfaces with personnel in Quality Assurance, Packaging, Processing, etc. to identify potential areas for product quality and process improvement.
4. Monitors systematic trends and identifies at risk areas/activities. Involves pulling data from automated equipment systems, customer feedback, CAPA software, and microbiological bulk/finished results.
KNOWLEDGE, SKILLS AND ABILITIES
Education: Bachelor’s degree in Engineering or related science field.
Experience: 3 - 5 years of experience working in cosmetic/consumer products, food, or drug in a manufacturing environment. Cosmetics experience is preferred.
1. Must possess strong technical skills. Experience with Good Manufacturing Practices.
2. Must possess excellent written and oral communication skills and the ability to facilitate communications between various groups to achieve quality objectives.
3. Must be detail driven and results-oriented to support independent decision making, and able to prioritize work per business needs in a fast paced environment.
4. Must have excellent interpersonal and leadership skills in order to effectively lead teams to meet objectives.
5. Must possess excellent project management skills in order to coordinate multiple projects and adhere to tight timelines.
6. Must have good presentation skills in order to provide training to various groups within the Company
7. Demonstrated ability to work in a team environment.
8. Proficient computer skills (Microsoft Office, document managements systems, etc.)
9. Experienced with Root Cause Analysis, ability to troubleshoot out-of-specification results, and perform OOS investigations.