Pharma CAPEX Project Engineer – GMP & Compliance

Endo; Village of Hobart (NY); Vor Ort; USD 84.000 - 114.000; Vollzeit

Zusammenfassung

Par Health is seeking a Project Engineer to manage capital expenditure projects in a pharmaceutical manufacturing setting, ensuring safety, on-time delivery, budget adherence, and regulatory compliance.

The role requires leading end-to-end CAPEX initiatives, coordinating engineering, quality, validation, and external vendors while maintaining robust documentation and support for validation efforts.

Qualifikationen

• Bachelor's degree in Engineering (Chemical, Mechanical, Electrical or related discipline).
• 1-3+ years experience in manufacturing environments, pharmaceutical or regulated preferred.
• Proven CAPEX project management experience.
• Strong GMP/regulatory knowledge.
• PM certification (PMP or equivalent).

Aufgaben

• Lead end-to-end execution of CAPEX projects including planning, design, procurement, construction, and commissioning.
• Develop project scopes, budgets, schedules, and resource plans.
• Coordinate cross-functional teams including engineering, quality, validation, manufacturing, and external vendors.
• Ensure compliance with cGMP, FDA, EMA, and other regulatory requirements.
• Oversee equipment selection, installation, and qualification (IQ/OQ/PQ).
• Manage contractors, suppliers, and construction activities on-site.
• Perform risk assessments and implement mitigation strategies.
• Track project performance and provide regular status updates to stakeholders.
• Drive continuous improvement and cost optimization in project execution.
• Ensure proper documentation and support validation efforts.

Kenntnisse

CAPEX management

GMP knowledge

PM certification

Ausbildung

Bachelor's in Engineering

Tools

CAD/CAM

Jobbeschreibung

Par Health is seeking a Project Engineer to manage capital expenditure projects in a pharmaceutical manufacturing setting, ensuring safety, on-time delivery, budget adherence, and regulatory compliance.

The role requires leading end-to-end CAPEX initiatives, coordinating engineering, quality, validation, and external vendors while maintaining robust documentation and support for validation efforts.