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Cleaning Validation Specialist

2 months ago

Monroe, United States Ssgnetwork Full time

Location Monroe, NC

We are actively seeking a Cleaning Validation Specialist to join its growing team in the Charlotte NC area. The Validation Engineer/Specialist will plan and schedule qualification projects, including the ability to develop, perform, maintain, and support qualification activities and documentation in accordance with cGMP requirements. Provide support to the vendors installation and qualification activities.

**Key Responsibilities****:**

* Lead Cleaning Validation / Verification of OSD and Sterile manufacturing equipment for new product introductions, product/process changes for capacity or continuous improvement projects in compliance with FDA regulations, Quality management systems, Good Manufacturing Practices.

* Experience in CIP/COP, SIP and manual cleaning validation activities in GMP environment. This position will interface with clients, lead team members of R&D, QC, Engineering, Operations and QA professionals.

* Responsible for preparing and executing CV for a variety of Process/Packaging equipment. This includes Risk Assessments, Worst Case Product Assessment and CV limits determination, Recovery Studies, Swab/Sample Qualification and Periodic review of CV status.

* Understanding of proper sampling technique for swab and rinse sampling. Develop CV sampling plans and provide training to collect swab and rinse samples within the manufacturing environment.

* Assist in the generation of User Requirement Specification and Impact Assessments to ensure the proper cleaning ability of the equipment and determine the impact of the system.

* Assist in creating the Standard Cleaning Procedures for manufacturing/packaging equipment and qualification related procedures.

* Able to follow-up and resolve comments, deviations, and technical issues with the qualification activities.

* Provide support in generation of Cleaning Validation Master Plan. Ensure it is current and the scheduled activities being implemented per agreed timelines.

* Must be able to work independently and in team environment to conduct qualification activities using a science and risk based approach.

* Must be able to lead project with minimal supervision.

* Coordinate the proper approval of plans, requirements, and protocols.

* Review completed protocols for completeness, cGMP compliance and data acceptability.

* Conduct regular project review meetings within the team, with cross functional teams and with the vendors to control the project time to time.

* Contribute to department efficiency initiatives.

* Support in presenting and defending qualification protocols/reports during regulatory inspections and internal audits.

**Education****:**

* Bachelor's degree in relevant scientific discipline (Engineering, Chemistry or Science) required. Equivalent experience will be considered.

**Experience****:**

* Minimum of 3 years of direct experience with project planning, development, and executing cleaning validation activities for OSD and Sterile equipment. Preferred overall experience in Pharmaceutical industry is 7 years.

* Must have excellent verbal communication and technical writing skills.

* Must have experience with aseptic gowning requirements and Clean room qualification. Hands on experience with following systems: interpreting P&IDs, Process Flow Diagrams, Piping and instrumentation Diagrams, equipment/system layouts, CIP skids, SIP systems, WIP skids, CIP/COP of manufacturing vessels and manual cleaning is required.

* Provide subject matter expertise in the cleaning validation for process equipment.

**Skills****:**

* Ability to work in a team structure; plan, organize and prioritize work.

* Ability to analyze quantitative data, create and/or edit written reports and be able to process information.

* Proficient in Microsoft Word, Excel, Power Point and Project.