Senior Engineering Leader

2 weeks ago


Philadelphia, Pennsylvania, United States Mantell Associates Full time

Mantell Associates is collaborating with a prominent Biologics organization to present an exceptional opportunity for a Senior Engineering Leader to become part of their expanding team.

Senior Engineering Leader - Key Responsibilities:

  • Direct and oversee a team of engineers to guarantee the prompt and compliant execution of projects.
  • Formulate and execute strategies and comprehensive plans for both new and existing manufacturing processes and machinery.
  • Supervise the qualification and validation of equipment, utilities, and systems, ensuring adherence to regulatory standards and internal protocols.
  • Engage with cross-functional teams, including quality assurance, engineering, and production, to ensure that validation activities are seamlessly integrated into the project lifecycle.
  • Create and uphold validation protocols, reports, and standard operating procedures (SOPs).
  • Conduct risk assessments and impact evaluations to identify critical parameters and ensure that suitable controls are established.

Senior Engineering Leader - Essential Qualifications:

  • Bachelor's or advanced degree in engineering or a related scientific field.
  • Experience in Project Engineering.
  • Over 10 years of experience in managing engineering at the site level.
  • Experience with managing engineering for projects with a CAPEX of 50M, along with operational responsibilities.
  • Background in Biotech/Biologics, with a focus on Process/Manufacturing equipment, and Utilities as a secondary priority.
  • Comprehensive understanding of validation principles, practices, and regulatory requirements (FDA, EMA, ICH).
  • Strong leadership and team management capabilities, with a focus on mentoring and developing a team of validation experts.
  • Exceptional communication and interpersonal skills, enabling effective collaboration with cross-functional teams.
  • Robust problem-solving and decision-making skills, emphasizing continuous improvement.

Mantell Associates specializes in headhunting within the Pharmaceutical and Life Sciences sectors.



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