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 email@example.com.