Job Details

Mindful Quality is hiring for a new role of a Sr. Cleaning Process Engineer. This Sr. Engineer is responsible for supporting cleaning process engineering, analysis and resolution of client's equipment issues, and support client's concerns around maintenance of equipment in cGMP facilities.

The Role

• Development of cleaning process or troubleshooting and resolution of client's cleaning process engineering issues.
• Analysis and resolution of client's equipment issue related to cleaning processes.
• Troubleshoot cleaning failures, develop, and optimize cleaning processes.
• Assess client's maintenance documents to identify regulatory concerns including potential corrective actions in alignment with industry best practices.
• Support the development of client's corrosion management programs
• Operation of Metallurgical laboratory equipment to perform sample evaluations
• Assist in developing and revising standard operating procedures, preventative maintenance, and work instructions
• Write, revise, and review cleaning and equipment related documents including Master Plans, Project Plans, Batch Records, Standard Operating Procedures, Forms, Protocol, Summary Reports, Forms, Risk Assessments, etc.
• Can lead client's project with minimal oversight.
• 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.
• Look for ways to continuously improve generated documentation
• Communicate effectively with team members and external vendors/clients
• Develop training materials for client staff based on SOPs authored.
• Mentor and train internal and client staff on engineering principles
• Other duties as assigned by manager

• Degree in Mechanical Engineering or Biochemical Engineering, other related fields, or equivalent training required.
• 2-5 years' work experience in metallurgy
• Formal training in risk analysis
• Thorough understanding of Quality systems
• High analytical ability where problems are complex
• 15+ years' experience in engineering preferrable in cleaning process design and equipment within pharmaceutical industry
• Must possess good analytical and problem-solving skills and statistical ability
• Strong working knowledge of Engineering principles, GMPs, and validation
• Hands-on experience with the following systems: CIP systems, COP systems, and parts washers.
• Proven ability to review, interpret and make scientific conclusions and recommendations based on data
• Ability to understand and extract necessary information from technical documents
• 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.
• Must be willing to lead staff, write protocol/reports, and execute validation activities as required to support client's needs.