Mantell Associates is currently partnered with a leading Biologics company on an exciting opportunity for an Engineering Manager to join their growing team.

Engineering Manager – Responsibilities:

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

Engineering Manager – Requirements:

• Bachelor’s or advanced degree in engineering or a related scientific discipline
• Project Engineering background 
• 10+ years experience managing engineering at site level 
• 50M CAPEX experience – managing engineering for this and operational tasks
• Biotech/biologics experience – Process/Manufacturing equipment priority, Utilities second
• 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
• 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 us at +44 (0)20 3854 7700.

Tagged as: Engineering