Validation Engineer I

3 weeks ago


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

Millstone Medical Outsourcing is seeking a skilled Validation Engineer I to join its Engineering Department. As a fast-growing, fast-paced medical service provider, we offer a dynamic work environment and opportunities for growth and development.

Key Responsibilities:
  • Document and execute equipment and process validations (IQ, OQ, PQ) on various types of manufacturing equipment and end-of-line processes
  • Creation of manufacturing work instructions
  • Interface with customers on technical issues, project timeline, and validation support
  • Actively participate on cross-functional teams to determine the root cause and corrective actions for problems associated with investigations
  • Provide support for operations and communicate with Program Managers
  • Assist with training of operations personnel
Requirements:
  • Bachelor's degree in Engineering
  • 1 year relevant experience
  • Technical writing proficiency to develop client process validations
  • Excellent communication skills
  • Excellent attention to detail, analytical and problem-solving skills
  • Experience with IQ, OQ and PQ protocols
  • Knowledge of GMPs
What We Offer:
  • Competitive salary
  • Health, dental and vision benefits
  • 401K with company match
  • Paid vacation, paid sick time, holiday pay, tuition reimbursement, and other voluntary benefits

Millstone Medical Outsourcing provides equal employment opportunity to all applicants and employees. We are an equal opportunity employer and welcome applications from diverse candidates.



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