Engineer - TS​/MS Cleaning Validation

Role Summary

Role

Summary:

The TS/MS Cleaning Validation Engineer provides technical leadership for cleaning validation activities in the Dry Packaging area (bottles and blister cards for tablets and capsules)  role supports new product commercialization and ongoing product operations, with a focus on cleaning validation, compliance, and continuous process improvement. Travel may be required up to 10%.

• Execute the technical agenda for the Dry Packaging cleaning and cleaning validation
• Prepare, review, and approve, as required, relevant technical documents such as: annual product reviews, change controls, regulatory submissions, deviations, validations, procedures, PFDs, PFMEAs, etc.
• Lead technical projects to improve cleaning processes and compliance
• Benchmark with sites in the network to drive technical consistency and knowledge sharing
• Serve as interface with upstream suppliers and Dry product network
• Own cleaning batch records and revisions, ensuring they are current and accurate
• Support equipment commissioning and qualification activities, as required
• Collaborate with Commercialization Project Manager as well as cross-functional tech transfer team members to commercialize new products in IDAP
• Understand the scientific principles required for Dry Packaging operations
• Support regulatory submissions as needed
• Understand and implement global requirements and standards into the Dry Process Team
• Provide technical leadership for the Process Team for cleaning activities
• Provide off hours support as needed

• Required:
  
  Bachelor’s degree or equivalent in a STEM discipline
• Required:
  
  Minimum 2 years of experience, with at least 1 year with cleaning/cleaning validation in a GMP environment
• Preferred:
  Technical / Scientific knowledge of cleaning regulatory requirements and practices
• Preferred:
  Clear understanding of cGMPs
• Preferred:
  Experience in pharmaceutical manufacturing
• Preferred:
  Good teamwork and interpersonal skills
• Preferred:
  Root Cause Investigation experience
• Preferred:
  Experience in technical leadership
• Preferred:
  Oral and written communication skills that demonstrate effective communication with all levels of an organization