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.

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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.