Pharma GMP Project Engineer - Site & Compliance Lead

Xtalks; Melrose Park (IL); On-site; USD 80,000 - 100,000; Full time

Benefits offered by this job

Medical, Dental, Vision

PTO

401K

Job summary

cGMP Consulting seeks an experienced engineer to design, communicate, implement and complete complex project plans in a pharmaceutical manufacturing environment. You will analyze feasibility, prepare detailed cost estimates, and coordinate vendors while ensuring compliance with FDA, OSHA, and local codes.

Responsibilities include preparing URS and safety assessments, reporting status to management, and driving energy efficiency and process improvements across facilities.

Qualifications

• Minimum 5 years of engineering experience; pharma manufacturing preferred.
• Excellent attention to detail and working knowledge of FDA regulations and GMP.
• Proficiency with statistical analysis tools is a plus.

Responsibilities

• Design, communicate, implement and complete complex engineering project plans in manufacturing.
• Evaluate feasibility, provide detailed time and cost analyses, and prepare BOMs.
• Ensure compliance with state, federal, local codes including FDA and OSHA requirements.
• Coordinate vendors, manage bid packages, and monitor safety and regulatory adherence.
• Prepare URS, risk and safety assessments as required for projects.
• Report project status to stakeholders and work with multi-functional teams.
• Identify energy savings opportunities and support ISO 50001 optimization where applicable.
• Assist manufacturing and maintenance with process improvements and cost reductions.

Skills

Attention to detail

Project management

Interpersonal skills

Statistical analysis tools

Regulatory compliance understanding

Education

Bachelor's degree in engineering or related field

Tools

MS Word

MS Excel

PowerPoint

Job description

cGMP Consulting seeks an experienced engineer to design, communicate, implement and complete complex project plans in a pharmaceutical manufacturing environment. You will analyze feasibility, prepare detailed cost estimates, and coordinate vendors while ensuring compliance with FDA, OSHA, and local codes.

Responsibilities include preparing URS and safety assessments, reporting status to management, and driving energy efficiency and process improvements across facilities.