Director of Engineering

5 days ago

Philadelphia, Pennsylvania, United States PCI Pharma Services Full time

Lead the Future of Engineering at PCI Pharma Services

As a Director of Engineering at PCI Pharma Services, you will be responsible for leading the engineering team at our CDMO manufacturing site. This role requires a strategic leader with an understanding of Pharmaceutical and medical device regulations, a passion for continuous improvement, and a commitment to quality and efficiency.

Key Responsibilities:

  • Develop and implement engineering strategies aligned with global engineering and company goals.
  • Lead, mentor, and develop a high-performing engineering team.
  • Foster a culture of innovation, collaboration, and continuous improvement.
  • Work closely with Operations, Quality, EH&S, and Sales and Project Management to ensure internal and external clients' requirements are met.

Process Development and Validation:

  • Work with OEMs and oversee the process development and validation of new automation equipment.
  • Ensure compliance with regulatory requirements (e.g., FDA, ISO 13485).
  • Collaborate with Operations and Quality to validate and run automation equipment for our customers.

Site Engineering:

  • Lead the facilities team for any building modifications and improvements.
  • Optimize manufacturing processes to improve efficiency, quality, and cost-effectiveness.
  • Implement lean and continuous improvement methodologies.

Quality & Compliance:

  • Ensure all engineering activities comply with regulatory standards and company policies.
  • Lead root cause analysis and corrective actions for product and process issues.

Project and Capital Management:

  • Manage multiple engineering projects, ensuring timely and successful completion.
  • Develop and manage capital budgets, timelines, and resource allocation.
  • Communicate project status and risks to senior management.
  • Work with sales/marketing when estimating cost, resources, and timing of new programs or changes to existing programs.

Requirements:

  • Bachelor's Degree in engineering or a related field and/or 10-15 years related experience and/or training.
  • Statistical and Advanced Mathematical Skills
  • Familiar with lean, CI, and six sigma
  • Hands-on engineering leader
  • Ability to prioritize multiple ongoing projects and activities to meet customer and company timelines
  • Full Professional Proficiency: Ability to speak, read, write, and present fluently and accurately on all levels pertinent to professional needs.
  • Ability to show success in managing employees.
  • Location requirement: Philadelphia, PA
  • Some travel will be required ~5%

Preferred:

  • Master's Degree (M.A.) in related field.
  • Pharmaceutical, Medical Device, or Life Science experience
  • Ability to set and achieve challenging goals.
  • Lean & Six Sigma Certifications

At PCI Pharma Services, we are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity – at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies, and programs, marketing approach, and workplace culture.

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