Talent.com
Senior Cleaning Validation Engineer (Remote)
Senior Cleaning Validation Engineer (Remote)Valid8 Financial, Inc. • Orlando, FL, US
No longer accepting applications
Senior Cleaning Validation Engineer (Remote)

Senior Cleaning Validation Engineer (Remote)

Valid8 Financial, Inc. • Orlando, FL, US
9 days ago
Job type
  • Full-time
  • Remote
Job description

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, as well as supporting client concerns around maintenance of equipment in cGMP facilities.

The Role

  • Development of cleaning processes or troubleshooting and resolution of client's cleaning process engineering issues.
  • Analysis and resolution of client's equipment issues 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.
  • Operate 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, SOPs, Forms, Protocols, Summary Reports, Risk Assessments, etc.
  • Lead client projects with minimal oversight.
  • Interact with team members and clients to create, review, and approve documentation within deadlines.
  • Plan and track project deliverables, coordinating with internal and external teams.
  • Create, develop, edit, and maintain high-quality documentation following internal and client style guidelines, standards, and templates, ensuring quality targets, timelines, and regulatory requirements are met.
  • Identify opportunities for continuous improvement of documentation.
  • Communicate effectively with team members and external vendors / clients.
  • Develop training materials for client staff based on SOPs.
  • Mentor and train internal and client staff on engineering principles.
  • Perform other duties as assigned by the manager.

The Candidate

  • Degree in Mechanical Engineering, Biochemical Engineering, or related fields, or equivalent training.
  • 2-5 years' experience in metallurgy.
  • Formal training in risk analysis.
  • Thorough understanding of quality systems.
  • High analytical ability for complex problems.
  • 15+ years' experience in engineering, preferably in cleaning process design and equipment within the pharmaceutical industry.
  • Strong analytical, problem-solving, and statistical skills.
  • Good knowledge of engineering principles, GMPs, and validation.
  • Hands-on experience with CIP, COP systems, and parts washers.
  • Ability to review, interpret, and make scientific conclusions based on data.
  • Proficiency in understanding and extracting information from technical documents.
  • Excellent grammar and writing skills.
  • Ability to work effectively within a team and independently, managing multiple tasks and meeting deadlines.
  • Advanced skills in Microsoft Word, Excel, and PowerPoint.
  • Willingness to travel worldwide to support client sites.
  • Willingness to lead staff, write protocols / reports, and execute validation activities.
  • Application Process

    Interested candidates can apply by providing their first name, last name, email address, location, phone number, resume, cover letter, salary requirements, work authorization status, sponsorship needs, professional qualifications, and highest education level.

    J-18808-Ljbffr

    Create a job alert for this search

    Validation Engineer • Orlando, FL, US