Manager of Validation Engineering - Biopharmaceutical

Posted 31 May 2023
Salary Competitive
LocationUnited States of America
Job type Full Time
Discipline Life Science Consulting
Contact NameStephanie Moreno

Job description

​Mantell Associates is currently partnered with a leading biopharmaceutical company on an exciting opportunity available for a Manager of Validation Engineering.


  • Are you looking to join a renowned biopharmaceutical company at the forefront of innovation?

  • Do you have extensive experience in validation engineering within the biopharmaceutical or pharmaceutical industry?

  • Do you enjoy leading a team and ensuring compliance with regulatory requirements?

This company is dedicated to developing and manufacturing cutting-edge biopharmaceutical products. They are seeking a Manager of Validation Engineering who will be responsible for overseeing the validation activities related to equipment, processes, and systems within the manufacturing facility.


Manager of Validation Engineering Responsibilities:

  • Lead and manage a team of validation engineers to ensure timely and compliant execution of validation activities

  • Develop and implement validation strategies and master plans for new and existing manufacturing processes and equipment

  • Oversee the qualification and validation of equipment, utilities, and systems, ensuring compliance with regulatory requirements and internal standards

  • Collaborate with cross-functional teams, including quality assurance, engineering, and manufacturing, to ensure validation activities are integrated seamlessly into the project lifecycle

  • Develop and maintain validation protocols, reports, and standard operating procedures (SOPs)

  • Perform risk assessments and impact assessments to identify critical parameters and ensure appropriate controls are in place

  • Stay current with regulatory requirements and industry best practices related to validation and ensure compliance with applicable regulations (FDA, EMA, ICH)


Manager of Validation Engineering Requirements:

  • Bachelor's or advanced degree in engineering or a related scientific discipline

  • Minimum of 8 years of experience in validation engineering within the biopharmaceutical or pharmaceutical industry, with at least 3 years in a leadership or management role

  • In-depth knowledge of validation principles, practices, and regulatory requirements (FDA, EMA, ICH)

  • Strong leadership and team management skills, with the ability to mentor and develop a team of validation professionals

  • Experience with the qualification and validation of equipment, utilities, and systems in a GMP environment

  • Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams

  • Strong problem-solving and decision-making abilities, with a focus on continuous improvement


Mantell Associates is a specialist Pharmaceutical and Life Sciences headhunting firm. For more information on this role, please contact Stephanie Moreno at 786-431-3404 or