Category: Manufacturing & Production

Employment Type: Direct Hire

Reference: BH-372193

Manufacturing Validation Engineer
Direct Hire
Location: McKinney, TX (Onsite)
Responsibilities:

• Manage validation projects, leading all documentation in compliance with regulatory expectations. (ISO/OSHA)
• Coordinate and oversee the execution of the validation master plan.
• Provide support for regulatory audits, submissions, and other auditor requests.
• Develop and execute test protocols.
• Create commissioning, qualification, and validation documents.
• Maintain validation documentation throughout its lifecycle.
• Assist in validating new equipment installations.
• Troubleshoot abnormal testing results or issues identified by colleagues.
• Ensure accurate records of all validation activities.
• Manage packaging performance and testing, collaborating with internal resources and suppliers.
• Troubleshoot packaging problems, offering timely and cost-effective solutions.
• Analyze engineering drawings and specifications for packaging requirements.
• Collaborate with global suppliers, engineering, product management, operations, and sourcing.
• Identify and implement cost-saving initiatives related to packaging materials and processes.
• Optimize packaging designs for manufacturability.
• Maintain familiarity with quality management system documentation for ISO13485 and 21CFR requirements.
• Lead and support continuous improvement projects.
• Support the safety committee in ensuring compliance with guidelines and regulations.
• Act according to company Core Values and Purpose.
• Exercise discretion and independent judgment on significant matters.
• Manage job-related stress and meet delivery deadlines.
• Follow OSHA and safety guidelines consistently.
• Demonstrate teamwork and adhere to company safety standards.

• Bachelor's degree in Mechanical, Industrial, or Packaging Engineering, or equivalent.
• Minimum of 3 years process validation experience.
• Minimum of 1 year packaging testing experience.
• Strong documentation skills.
• Attention to detail and analytical thinking.
• Ability to provide technical support and multitask effectively.
• Fluency in English.
• Skilled in time management and problem-solving.
• Good administrative skills and proofreading abilities.
• Ability to work independently and learn new tasks.
• Physical capability to meet job demands.
• Availability for evening/weekend work as needed.