Job Details

Mindful Quality is a growing consulting firm in the Biotechnology and Pharmaceutical industries. Mindful Quality specializes in cleaning validation, process development, project management, and regulatory guidance related to manufacturing quality assurance.

The Cleaning Validation Engineer is responsible for cleaning process engineering and validation for our clients. The position will involve supporting cleaning cycle development, cleaning validation, and continuous cleaning monitoring in cGMP facilities. Ideal candidate has experience in cleaning validation including CIP, COP, and manual cleaning.

The Role

• Assess client's cleaning validation documents to identify regulatory concerns including potential corrective actions in alignment with industry best practices.
• Troubleshoot cleaning failures, develop, and optimize cleaning processes.
• Write, revise, and review cleaning related documents including Master Plans, Project Plans, Batch Records, Standard Operating Procedures, Forms, Protocol, Summary Reports, Forms, Risk Assessments, etc.
• 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.
• Create, manage, and help close out protocol exceptions and deviations
• Manage protocol execution paperwork as needed to support clients.
• Create and manage Change Control and CAPA documentation
• Look for ways to continuously improve generated documentation
• Communicate effectively with team members and external vendors/clients
• Develop training materials for manufacturing staff based on SOPs authored.
• Mentor and train client staff on cleaning validation principles
• Other duties as assigned by manager

• Degree in Chemistry, Biochemistry, Pharmacy, Engineering, or other related fields
• 5+ years' experience in cleaning validation within a regulated manufacturing environment. Preferrable Pharmaceutical or Biotechnology industry.
• Working knowledge of GMPs - Preferred
• Hands-on experience with the following systems: CIP systems, parts washers, manual cleaning is required.
• Experience with rinse and swab sampling techniques
• Proven ability to review, interpret and make scientific conclusions and recommendations based on data
• Ability to understand and extract necessary information from technical documents
• 2-5 years of 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 to meet critical milestones and goals. - Required
• Able to effectively manage workload and prioritize activities
• Proficient computer skills
• Advanced knowledge of Microsoft Word/Excel/PowerPoint - Required
• Must be willing to travel to client sites worldwide to support work as needed.