Senior Validation Engineer

1 day ago


Boston, Massachusetts, United States Practical Applications Full time
Senior Validation Engineer

Millstone Medical Outsourcing is seeking a highly skilled Senior Validation Engineer to lead our engineering team in ensuring the successful completion of validation activities.

Key Responsibilities:
  • Lead the engineering team in validation activities, ensuring compliance with regulatory standards and company policies.
  • Perform process analysis, improvements, and validations on manufacturing equipment and end-of-line processes.
  • Develop and maintain clear and concise work instructions, test methods, and visual standards.
  • Interface with customers on technical issues, project timelines, and validation support.
  • Actively participate in cross-functional teams and provide technical support for operations.
Requirements:
  • Bachelor of Science in Mechanical Engineering, Chemical Engineering, or Bioengineering with 5-8 years of engineering experience.
  • Strong interpersonal and organizational skills, with excellent leadership and project management abilities.
  • Ability to apply fundamental engineering principles to resolve issues and communicate effectively with all levels of the organization.
  • Knowledge of applicable regulatory standards, including FDA, ISO, OSHA, EPA, and CFR.
What We Offer:
  • Competitive salary and benefits package.
  • Opportunities for growth and professional development.
  • A dynamic and collaborative work environment.

Millstone Medical Outsourcing is an equal opportunity employer and welcomes applications from diverse candidates. We are committed to creating an inclusive and respectful workplace.



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