Validation Responsibilities: 

• Work as a subject matter expert on validation of manufacturing processes
• Perform validation projects based on customer's engineering specifications
• Author and execute validation protocols within team framework
• Write validation reports related to transfer of the product from development to manufacturing and revalidation reports related to previously validated processes.
• Work with other teams at Donatelle and with customers to ensure validation activities meet internal and external customer's requirements
• Responsible for improving standard operating procedures (SOP's) and any other associated documentation required for manufacture of new products and/or process changes
• Participate in cross functional teams
• Resolve or address customer concerns, supply chain issues, and corrective actions effectively and efficiently
• Effectively manage projects so they remain within budget, on time, and meets all the quality requirements of the project
• Effectively maintain and communicate project statuses, progress toward key milestones and critical path deliverables
• Create master validation plans, characterization sample requests, validation sample requests, inspection requests, BOM/process flow deviations, sampling plan justifications, inspection plans, control plans, supplied data agreements, and certificates of compliance.
• Work with product development team to manage execution of validation runs (OQ and PQ) and provide solutions to validation challenges.
• Create and revise process failure modes and effects analyses (pFMEAs) and lead cross functional pFMEA working meetings.
• Work with Precision Engineer and inspection team to develop inspection methods, fixtures, gauges, quality inspection work instructions, and perform measurement systems analysis (MSA)

General Responsibilities:

• Interact with customers, suppliers, and coworkers in a professional manner
• Follow safety requirements as outlined in the safety manual
• Responsibility to protect Donatelle confidential information and Intellectual Property
• To effectively demonstrate sound judgment to protect Donatelle confidential information and Intellectual Property
• Support other positions on the engineering teams as needed including Project Engineers and Manufacturing Engineers.

Preferred Qualifications:                                                                                                                                              

Education/Experience:

• Minimum requirement is BS in engineering or equivalent 
• ASQ CQE certification preferred
• Process Validation Professional Certification preferred
• 4+ years- of experience as a validation engineer preferred
• General knowledge in precision manufacturing

Other Qualifications and Desired Skills:

• Knowledge of Current Good Manufacturing Practices (CGMP)/Quality System Regulation (QSR), ISO 13485.
• Strong problem solving and troubling shooting abilities
• Good communication and human relation skills
• Project management skills
• Proficient computer skills, including MS Office, Minitab statistical software, Adobe Acrobat