Pharma CAPEX Project Engineer – GMP and Regulatory

Paladin Labs Inc.; Village of Hobart (NY); On-site; USD 84,000 - 114,000; Full time

Job summary

Par Health is seeking a Project Engineer to lead capital expenditure projects within a pharmaceutical manufacturing environment. You will ensure safe, on-time, and within-budget delivery while complying with GMP, FDA, and other regulatory standards.

You will manage scopes, budgets, schedules, and cross-functional teams, oversee equipment selection and IQ/OQ/PQ qualification, and supervise on-site contractors with a focus on risk management and cost optimization.

Qualifications

• Bachelor’s degree in Engineering required (Chemical, Mechanical, Electrical or related).
• 1–3+ years in manufacturing environments; pharmaceutical/regulatory preferred.
• PM certification (PMP or equivalent) a plus.

Responsibilities

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

Skills

Project management

Communication

Regulatory awareness

Problem solving

Attention to detail

Education

Bachelor's Degree in Engineering

Tools

IQ/OQ/PQ

CAD/CAM

Job description

Par Health is seeking a Project Engineer to lead capital expenditure projects within a pharmaceutical manufacturing environment. You will ensure safe, on-time, and within-budget delivery while complying with GMP, FDA, and other regulatory standards.

You will manage scopes, budgets, schedules, and cross-functional teams, oversee equipment selection and IQ/OQ/PQ qualification, and supervise on-site contractors with a focus on risk management and cost optimization.