Pharma CAPEX Project Engineer | GMP Compliance

Paladin Labs Inc.; New York, Northern (NY, KY); Hybrid; USD 84,000 - 114,000; Full time

Job summary

Par Health in New York is seeking a Project Engineer to lead CAPEX projects in a pharmaceutical manufacturing setting. You will plan, design, procure, construct, and commission capital projects to meet GMP and regulatory requirements.

The role collaborates with engineering, quality, validation, manufacturing, and external vendors to deliver safe, on-time, within-budget results. Candidates should have a Bachelor's in Engineering and 1–3+ years of experience, with PMP or equivalent certification

Qualifications

• Bachelor’s Degree in Engineering (Chemical, Mechanical, Electrical or related discipline).
• 1–3+ years of experience in manufacturing environments (Pharmaceutical or regulated manufacturing preferred).
• Proven experience managing CAPEX projects.
• Strong knowledge of GMP and regulatory requirements.
• Project Management certification (PMP or equivalent).
• Excellent communication and stakeholder management abilities.
• Technical expertise in process equipment and facility systems.
• Problem-solving mindset with attention to detail.
• Ability to manage multiple projects simultaneously.

Responsibilities

• 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.

Skills

Project management

GMP knowledge

Regulatory knowledge

Communication

Stakeholder management

Problem solving

Lean Six Sigma

Automation awareness

CAD/CAM

Education

Bachelor’s Degree in Engineering (Chemical, Mechanical, Electrical or related discipline)

Job description

Par Health in New York is seeking a Project Engineer to lead CAPEX projects in a pharmaceutical manufacturing setting. You will plan, design, procure, construct, and commission capital projects to meet GMP and regulatory requirements.

The role collaborates with engineering, quality, validation, manufacturing, and external vendors to deliver safe, on-time, within-budget results. Candidates should have a Bachelor's in Engineering and 1–3+ years of experience, with PMP or equivalent certification