Job Details

The Cleaning Validation Coordinator is responsible for collaborating with internal and external client teams to track project timelines and deliverables. The ideal candidate will have a strong desire to learn cleaning validation while demonstrating excellent organizational and communication skills that increase client confidence and support product deliverables in alignment with agreed timelines. This role will assist with developing and maintaining project plans, resource estimates, and timeline forecasts while also coordinating activities and supporting the team, with cleaning validation activities.

The Role

• Communicate effectively with team members and external vendors/clients
• Develop, coordinate, and track timelines/deliverables for customer/internal projects. This includes coordination with internal and external team members.
• Interact with team members and clients to create, review, and approve documentation per timeline.
• Provide weekly updates to management on schedule, progress, obstacles, and report issues that may affect ultimate results.
• Manage and organize project documents
• Assist business development in managing the customer relationship, and maintaining client trust, confidence, and faith in the consultant team.
• Look for ways to continuously improve generated documentation
• Support the assessment of client's cleaning validation documents to identify regulatory concerns including potential corrective actions in alignment with industry best practices.
• Remain 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.
• Assist with the development of assessment concerns related to the client's cleaning validation program and draft improvement plans to address concerns identified.
• 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.
• Other duties as assigned by manager

• Degree in Chemistry, Biochemistry, Engineering, or other related fields
• Driven, hard-working, and determined to succeed
• Formal project management training is preferred
• Organized and efficient, with excellent time management skills
• Experience in the pharmaceutical industry preferably within validation.
• Working knowledge of cGMP requirements, ICH, FDA, and other pharmaceutical industry regulatory guidelines is highly desired.
• 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