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.
