Director Engineering

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.

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Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.

Job Title: Director Engineering

Department/Group: Commercial Segment, Engineering

Location: Philadelphia, PA

Reports to: Site General Manager

FLSA Status: Exempt

The Director of Engineering will lead the engineering team at our CDMO manufacturing site, overseeing all aspects of process engineering, project engineering, capacity management and capital management. 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.

Essential Duties and Responsibilities: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following but other duties may be assigned.

Leadership & Strategy:

• Develop and implement engineering strategies aligned with global engineering and the 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 OEM’s 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.
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