Senior Project Engineer

Job Description

The Senior Project Engineer provides expertise primarily in the areas of pharmaceutical facility engineering. This position will manage large scale projects and multi-disciplinary teams. The project engineer will also provide technical direction for complex projects and exhibit superior communication skills with all levels of employees. The individual will act as an authority in pharmaceutical engineering and provide leadership and guidance to others.

Provides expert technical support of engineering facility projects including facility and utility expansion, compliance upgrades, cost reduction, process improvements, and construction projects. Design, optimize and implement site manufacturing processes to improve efficiency, quality and sustainability. Oversee and assess existing processes and workflows. Establish and track process metrics to monitor process stability and discover areas for improvement. Manage comprehensive compliance with cGMP, USP, and global regulatory standards (FDA/EMA) across local and international facility operations.

Execute end-to-end product life cycle management, maintaining ownership of the entire process from initial quotation through to product retirement. Own the end-to-end specification process—including URS, FRS, and DDS—and the generation of technical RFQs for external contractors and OEMs to ensure accuracy in project bidding and delivery. Develop and execute validation studies to test and qualify new and improved manufacturing processes. Generate reports summarizing results of studies to document data collected; utilize data obtained to qualify site processes.

Analyze cross-departmental data trends to identify and mitigate risks to sterile product integrity. Lead the implementation of proactive CAPAs to resolve adverse conditions and ensure continuous compliance. Participate in or perform deviation investigation and evaluation of impact. Oversee technical requirements for cleanroom classifications and aseptic processing, including sterilization, depyrogenation, media fills, and environmental control.

Qualifications

• Bachelor of Science; Major: Mechanical, Chemical, Bioengineering, or similar engineering discipline required
• 5-10 years related pharmaceutical experience or FDA regulated industry experience required
• Supervisory or other Leadership Experience required
• Project Management required
• Statistical Analysis preferred
• Leverage Six Sigma preferred
• Aseptic Manufacturing preferred
• Fill finish experience preferred

Benefits

• Hiring Wage: $103,050.00 – $164,900.00, with opportunities for growth, promotion, and annual raises.
• Starting on your first day, you receive: Medical, Dental & Vision coverage
• Flexible Spending Accounts (FSA) & Health Savings Accounts (HSA)
• Life & AD&D Insurance
• Short-Term & Long-Term Disability Insurance
• Employee Assistance Program