The Cleaning Validation Associate is responsible for assisting with the development of cleaning processes and cleaning validation activities for our clients. The position will support internal and external client teams with cleaning cycle development, cleaning validation, and continuous cleaning monitoring in cGMP facilities. The ideal candidate has a strong understanding of chemical engineering and a strong desire to learn cleaning validation including CIP, COP, and manual cleaning.
The Role
- Support the assessment of client’s cleaning validation documents to identify regulatory concerns including potential corrective actions in alignment with industry best practices.
- Support troubleshooting cleaning failures, development, and optimization of cleaning processes.
- Remains current with the cleaning processes and validation guidances.
- Research regulatory guidance and industry best practice documents related to a specific topic of concern
- Utilize technical writing skills to write, revise, and review cleaning related documents including Master Plans, Project Plans, Batch Records, Standard Operating Procedures, Forms, Protocols, Summary Reports, and Risk Assessments.
- Development of assessment concerns related to client’s cleaning validation program and draft improvement plans to address concerns identified.
- Interact with team members and clients to create, review, and approve documentation per timeline.
- Plan and track project deliverables. This includes coordination with internal and external team members.
- Create, develop, edit, and maintain high-quality documentation following internal and client style guidelines, document standards, and templates, while ensuring that quality targets, timelines, and regulatory requirements are met.
- Manage and organize project documents
- Look for ways to continuously improve generated documentation
- Communicate effectively with team members and external vendors/clients
- Other duties as assigned by manager
The Candidate
- Degree in Chemical Engineering, Engineering, Chemistry, Biochemistry, or other related fields
- Driven, hard-working, and determined to succeed
- Organized & efficient, with excellent time management skills
- Experience in cleaning validation within the pharmaceutical industry.
- Hands-on experience with the following systems: CIP systems, parts washers, manual cleaning is preferred.
- Working knowledge of cGMP requirements, ICH, FDA, and other pharmaceutical industry regulatory guidelines is highly desired.
- Experience with rinse and swab sampling techniques
- Strong technical skills to review, interpret, and make scientific conclusions and recommendations based on data
- Ability to understand and extract necessary information from technical documents
- Technical writing experience
- Excellent grammar and writing skills – Required
- Effectively work within a team environment and interface with peers, management, etc.
- Ability to work independently, handle multiple tasks simultaneously, and meet critical milestones and goals. – Required
- Able to effectively manage workload and prioritize activities
- Proficient with MacOS
- Advanced knowledge of Microsoft Word/Excel/PowerPoint – Required
- Must be willing to travel to client sites worldwide to support work as needed.
- Experience working in a global remote team environment