Engineering Manager – Biologics

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Posted August 2, 2024
Location Texas, USA
Job TypeContract, Full Time
Market Consulting
VerticalEngineering

Rhys Jones

Mantell Associates

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

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