Cleaning Validation Specialist

2 weeks ago


Monroe, North Carolina, United States Ssgnetwork Full time
Cleaning Validation Specialist

We are seeking a highly skilled Cleaning Validation Specialist to join our team at Ssgnetwork in the Charlotte, NC area.

The ideal candidate will have a strong background in cleaning validation, with experience in planning and executing qualification projects for OSD and Sterile equipment. The successful candidate will be responsible for developing, performing, maintaining, and supporting qualification activities and documentation in accordance with cGMP requirements.

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.
  • Interface with clients, lead team members of R&D, QC, Engineering, Operations and QA professionals.
  • Prepare and execute CV for a variety of Process/Packaging equipment.
  • 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.
  • Follow-up and resolve comments, deviations, and technical issues with the qualification activities.
  • Provide support in generation of Cleaning Validation Master Plan.
Requirements:
  • Bachelor's degree in relevant scientific discipline (Engineering, Chemistry or Science) required.
  • 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.
  • Excellent verbal communication and technical writing skills.
  • Experience with aseptic gowning requirements and Clean room qualification.
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.


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