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Senior Validation Engineer

2 months ago

Fall River, Massachusetts, United States Millstone Medical Full time
About the Role

We are seeking a highly skilled Validation Engineer to join our team at Millstone Medical Outsourcing. As a key member of our operations team, you will be responsible for executing and documenting equipment and process validations (IQ, OQ, PQ) on various types of manufacturing equipment and end-of-line processes.

Key Responsibilities
  • Equipment and Process Validation: Document and execute Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols for various manufacturing equipment and end-of-line processes.
  • Manufacturing Work Instructions: Develop, maintain, and update manufacturing work instructions to ensure that validated processes are accurately followed in production.
  • Customer Interface: Serve as a technical liaison between the company and customers, addressing technical issues, project timelines, and validation support.
  • Cross-Functional Team Participation: Actively participate in cross-functional teams to investigate and determine the root cause of issues and develop corrective actions.
Requirements
  • Education: Bachelor's degree in Engineering is required.
  • Experience: Depending on the level of the position, 4-8 years of relevant experience in validation engineering, preferably in a manufacturing environment.
  • Skills: Strong technical writing skills, excellent communication skills, and exceptional attention to detail, analytical abilities, and problem-solving skills.
About Millstone Medical Outsourcing

Millstone Medical Outsourcing provides equal employment opportunity to all applicants and employees. We are a fast-growing, fast-paced medical service provider for the top Orthopedic companies in the industry. Our business focus is sterile and non-sterile packaging of medical devices.

We are FDA and ISO registered and employ a detailed internal quality system to ensure ISO compliance. Our Total Rewards Benefits Program supports the physical and emotional well-being of our employees and their families.