Mantell Associates is currently partnered with the most innovative medical device company on an exciting opportunity and is in search for a Senior Engineering Manager.
Senior Engineering Manager - 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
Senior Engineering Manager - Requirements:
Bachelor's or advanced degree in engineering or a related scientific discipline
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 in medical devices, knowledge of FDA Quality System Regulations (QSRs) and/or ISO 13485, and other medical device industry experience
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 us at +44 (0)20 3854 7700.