Project Engineer III

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

We are PCI.

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.

As a Project Engineer III - Drug Delivery, you will lead the execution of high-impact engineering projects supporting the development and commercialization of pharmaceutical products. This is a highly visible role that combines deep technical expertise with project leadership, requiring close collaboration with internal and external stakeholders.

You will play a pivotal role in the industrialization of combination drug delivery systems, including auto-injectors used in diabetes management-cutting-edge technologies that directly impact patient outcomes and global health.

You'll also mentor junior engineers and serve as a key technical interface for global partners, ensuring every project is delivered with precision, innovation, and speed. You'll be part of a tight-knit, cross-functional team that values collaboration, open communication, and giving every team member a voice throughout the planning and execution phases.

This is more than a role-it's a career path, with our Project Engineers being promoted to senior-level Project Engineering positions including Project Engineering Manager positions.

Key Responsibilities:

Project Management & Execution

• Lead complex engineering projects from initiation through completion, ensuring alignment with quality, cost, and delivery goals.

• Manage project plans, scopes, timelines, and budgets, ensuring execution excellence at every step.

• Coordinate with vendors and review project documentation to ensure timely completion and compliance with specifications.

• Lead projects involving high-speed assembly and packaging of combination medical devices, including auto-injectors.

Technical Leadership

• Oversee design transfer and industrialization of drug delivery platforms, ensuring smooth scale-up to commercial production.

• Apply engineering best practices to optimize manufacturability, reliability, and regulatory compliance.

• Conduct risk assessments (e.g., FMEA, pFMEA) and lead process improvement initiatives across the product lifecycle.

• Serve as a mentor to Project Engineers I and II, contributing to a culture of growth and continuous improvement.

Client & Cross-Functional Collaboration

• Act as a technical liaison with customers, regulatory stakeholders, and contractors.

• Collaborate with Quality, Validation, Manufacturing, and Business Development to ensure cross-functional success.

• Participate in client-facing meetings, ensuring PCI's engineering efforts align with evolving partner expectations.

• Contribute to engaging, transparent discussions during project planning and execution-your voice matters here.

Compliance & Process Optimization

• Ensure full compliance with all PCI policies and relevant regulations including 21 CFR Part 820, ISO 13485, ISO 11608, and ISO 14971.

• Lead efforts to implement corrective actions and troubleshoot technical issues.

• Utilize Lean Six Sigma and operational excellence methodologies to drive efficiency and quality.

Qualifications - Required:

• Bachelor's degree in Mechanical, Electrical, Chemical, Biomedical Engineering, or related field.

• 10 years of experience in project engineering, manufacturing, or construction in regulated industries.

• Strong understanding of product design, process optimization, and risk mitigation strategies.

• Excellent communication skills (verbal and written) with the ability to lead and influence.

• Proficiency in MS Project, AutoCAD, SAP, Excel, and other project management tools.

• Proven ability to manage multiple priorities in a dynamic environment.

Qualifications - Preferred:

• PMP certification or similar project management credential.

• Lean Six Sigma certification or equivalent process improvement training.

• Familiarity with combination products or medical device packaging equipment.

• Certifications in cGMP, LEED, OSHA, or related disciplines.

The base salary hiring range for this position is ($97,280 - $115,520)plus eligibility for an annual performance bonus. Final offer amounts are determined by multiple factors including but not limited to specific and relevant experience, education, credentials, geography, and subject matter expertise. PCI offers full-time employees a competitive benefits package that includes paid time off, health insurance coverage (including dental and vision), flexible spending account, and 401(k).

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Join us and be part of building the bridge between life changing therapies and patients. Let's talk future

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.