Senior Cleaning Process Engineer; Remote

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

The Candidate

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

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.

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