Project Engineer III, Pharmaceutical Manufacturing

Key Responsibilities

• Lead CAPEX projects including facility expansions, utility upgrades, equipment installations, and manufacturing process improvements.
• Manage projects from concept through commissioning, qualification, validation, and operational handoff.
• Develop project plans, budgets, schedules, and risk mitigation strategies.
• Coordinate contractors, vendors, OEMs, and cross-functional stakeholders.
• Lead FAT, SAT, and CQV activities, including URS, DQ, IQ, OQ, and PQ documentation.
• Support new product introductions, process optimization, and equipment lifecycle management.
• Drive root cause investigations, CAPAs, and continuous improvement initiatives.
• Ensure compliance with GMP, FDA, and internal quality system requirements.

Required Qualifications

• Bachelor's degree in Engineering (Mechanical, Chemical, Industrial, Pharmaceutical, or related discipline).
• 4+ years of engineering experience in pharmaceutical, biotechnology, medical device, or other highly regulated manufacturing environments.
• 2+ years of direct experience in Commissioning, Qualification, and Validation (CQV).
• Proven experience managing CAPEX projects and equipment implementation.
• Strong understanding of GMP manufacturing, validation, and quality systems.
• Experience working in cleanroom environments.

Preferred Qualifications

• Experience within a CDMO environment.
• Experience supporting new product introductions and manufacturing scale-up activities.
• Experience working directly with vendors, contractors, and regulatory auditors.

Target Salary Range: $125,000 - $135,000

Individual compensation packages are based on various factors unique to each candidate, including skill set, experience, qualifications, and other job-related reasons.