Job Summary

The Validation Engineer is responsible for executing and documenting equipment and process validations (IQ, OQ, PQ) on various types of manufacturing equipment and end-of-line processes. This role involves interfacing with clients regarding all qualification details, technical issues and supporting project deliverables. Depending on the level of the position, the Validation Engineer may lead QA projects of moderate scope and duration or independently perform detailed engineering tasks.

Essential Duties and Responsibilities

• Fulfill validation engineering role on New Product Development team (conception to launch) and sustaining project processes related to validations.
• Complete planning and execution of design controls, risk management, test method development and validation, and design verification/validation for new and existing products.
  • Risk management: DFMEA, PFMEA, PRA
  • Validations: IQ, OQ, PQ etc.
  • Create and support the development and validation of new test methods/equipment.
  • Aid in creating design controls for validation and execution of verification of design controls per project requirements.
• Support Regulatory Affairs with creating submissions and responding to submission questions as needed.
  • Regulatory realms which this engineering role will be involved in: ISO 13485, cGMP, Sterilization (ISO 11135, ISO11137, etc.), standard
  • Ensure compliance with industry-specific regulations and standards.
• Primary responsibility is New Product Development; secondary responsibility is Continuous improvement of validation processes.
• Continued support and optimization of Currier New Product Development deliverables and processes.
• Participate and lead New Product Development Phase Reviews
• Develop the strategy and manage the execution of Validation protocols, which include, but are not limited to, tool sampling, tool qualification, automation SAT, FAT acceptance criteria.
• Generate validation protocols, manage validation protocol test execution, investigate root cause, analyze data, and create reports for the execution of protocols.
• Provide directions to quality, process and production engineering and or technicians supporting assigned projects for validation purposes.
• Support the transfer of new product development projects from development to production.
• Ability to read, analyze, and interpret technical procedures or government regulations.
• Ability to write reports, correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of department heads, managers, and clients.
• Ability to analyze and report data in a comprehensive and cohesive manner, which documents results, deviations, and corrective actions in an organized manner.

Requirements

• Bachelors Engineering Degree (optional): Mechanical, biomedical, chemical, industrial, plastics, materials, etc.
• Experience in medium/high volume Medical Pharmaceutical Industry is highly desirable.
• Design Assurance: 2-5 years.
• Test Method Development: 2-5 years.
• Med-tech New Product Development: 2-5 years
• Generate test protocols: 2-5 years.
• Technical Report Writing: 2-5 years.
• Plastics IM, EBM, ISBM, & IBM experience is desirable.
• Excellent verbal and written communication skills – including the ability to contribute technically to and work within cross-functional team environments.
• High personal/professional integrity, trustworthiness, strong work ethic, and ability to work independently.
• Ability to work in a dynamic and collaborative environment and maintain a results-oriented, positive, “can-do” attitude and ability to work well under pressure.
• Strong organizational and multitasking skills, with a high level of attention to detail and a proactive approach to problem-solving.
• Ability to read, analyze, and interpret technical procedures or government regulations.
• Ability to write reports, correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of department heads, managers, and clients.
• Proficiency in Microsoft Office Suite (Outlook, Word, Excel, PowerPoint, Minitab).

Benefits

• Standard Health, Dental, Vision Benefits.
• Generous PTO.
• 401K Match.