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

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.
• Work with sales/marketing when estimating cost, resources and timing of new programs or changes to existing programs.

Qualifications: The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Required:

• 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

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Equal Employment Opportunity (EEO) Statement:
PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

At PCI, Equity and Inclusion are at the core of our company’s purpose: Together, delivering life-changing therapies. 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.