Manufacturing Validation Engineer

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.

Requirements:

• 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.

#manufacturing #validation #compliance

Note: Any pay ranges displayed are estimations.  Actual pay is determined by an applicant's experience, technical expertise, and other qualifications as listed in the job description.  All qualified applicants are welcome to apply.

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Visit https://www.yoh.com/applicants-with-disabilities to contact us if you are an individual with a disability and require accommodation in the application process.

Founded in 1940, Yoh operates from 75 locations throughout North America and is headquartered in Philadelphia, PA. Yoh was the nation’s first technology staffing firm. As a business unit of Day & Zimmermann, Yoh has a flourishing global footprint, as our parent company operates from more than 150 worldwide locations.
Company Website: https://www.yoh.com/