Job Description Summary

The Project Engineer is responsible for managing and executing capital expenditure projects within a pharmaceutical manufacturing environment. This role ensures projects are delivered safely, on time, within budget, and in compliance with regulatory standards (GMP, FDA, etc.).

Job Description

ESSENTAIL FUNCTIONS:
• 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.

DEPARTMENT SPECIFIC/NON-ESSENTIAL FUNCTIONS:
• Perform additional duties and special projects as assigned by department leadership.
• Support continuous improvement initiatives within the department.
• Assist with cross-functional projects and interdepartmental coordination.
• Participate in training sessions, workshops, and professional development activities.
• Maintain departmental documentation, reports, and records as required.
• Provide backup support for other team members during absences or peak workloads.
• Contribute to process optimization and efficiency improvements.
• Attend meetings and provide input on departmental goals and performance.
• Support implementation of new tools, systems, or procedures within the department.
• Ensure compliance with company policies and relevant regulatory requirements when performing assigned tasks.

MINIMUM REQUIREMENTS:

Education:
Bachelor's Degree in Engineering (Chemical, Mechanical, Electrical or related discipline)

Experience:
1-3+ years experience in manufacturing environments. (Pharmaceutical or regulated manufacturing preferred)

Preferred Skills/Qualifications:
• Proven experience managing CAPEX projects.
• Strong knowledge of GMP and regulatory requirements.
• Project Management certification (PMP or equivalent )

Other Skills:
• Strong project management and organizational skills.
• 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.

Competencies:
• CAD/CAM Proficiency
• Problem Solving & Root Cause Analys
• Continuous Improvement (Lean/Six Sigma)
• Automation & Industry 4.0 Awareness

WORKING CONDITIONS:
• Position will work both an office environment and in a manufacturing plant environment.
• Must be able to wear the required Personal Protective Equipment (PPE) out on the plant site as deemed necessary by EH&S.
• Occasional travel required.

The expected base pay range for this position is $83,895 -$113,505. Please note that base pay offered may vary depending on factors including job-related knowledge, skills, and experience.