Validation engineer

Responsibilities

• Provide interpretation and guidance on regulations, corporate, divisional, and site local procedures related to validation activities.

• Participate in the Corporate Validation Team to develop and revise validation procedures and templates, ensuring compliance with current regulatory standards and company objectives.

• Participate in corporate and local validation teams to discuss, provide feedback, and approve revisions to validation procedures.

• Represent validation at both internal and external audits.

• Work as part of several cross-functional local and global teams; visit and work on manufacturing sites as required, on a hybrid basis.

• Guide the definition of validation strategies for highly complex validation projects across multiple sites.

• Ensure that validation practitioners receive training and coaching to effectively support and perform validations for current and anticipated projects.

• Ensure appropriate systems are in place to evaluate changes to validated/qualified systems, maintaining their validated/qualified state.

• Utilize quality engineering tools, statistical methods, design development methods, process development/control methods, and process verification/validation planning to incorporate quality into new and existing products.

• Implement and develop the validation process for newly acquired sites as part of mergers and acquisitions teams.

• Work closely with product transfer, NPI, NPD, and AO teams.

• Lead validation continuous improvement projects.

• Implement lean and Six Sigma initiatives and lead teams to apply these methodologies.

• Act as the Subject Matter Expert responsible for at least two validation specialties and provide primary support for those specialties, such as Computer System Validation (CSV) or Qualification of Buildings, Facilities and Utilities (BFU).