Principal Engineer (Filling & Lyophilization)

Location: United States; up to 40% travel, including international travel to plant sites and vendor facilities. Work takes place in office environments, active construction sites, and cGMP cleanrooms.

Salary: $120,200–$144,100 per year.

Company

hirify.global is a global contract development and manufacturing organization supporting pharmaceutical and biotech companies with drug development and manufacturing services.

What you will do

• Lead filling and lyophilization equipment engineering for major $10M–$50M+ capital projects from conceptual design through commissioning, qualification, and validation.
• Drive technical transfers of API and drug product programs with global program management and site technical operations teams.
• Author user requirement specifications, support vendor selection and capital cost estimation, and lead FAT/SAT for fill lines, isolators, lyophilizers, VHP systems, and capping equipment.
• Mentor site engineering teams, share best practices, and drive technical standardization across the hirify.global network.
• Troubleshoot complex equipment deviations, improve OEE, reduce cycle times, and execute cost-improvement programs.
• Manage engineering firms, equipment vendors, field contractors, and compliance with cGMP, EU Annex 1, FDA guidance, and global regulatory standards.

Requirements

• Bachelor’s degree in Mechanical, Chemical, Electrical, Biomedical, or a related engineering discipline.
• 10+ years of pharmaceutical engineering experience in sterile drug product manufacturing or CDMO technical operations.
• Proven experience leading major capital equipment execution projects exceeding $10M.
• Advanced expertise in aseptic processing, high-speed sterile filling for vials, syringes, and cartridges, and barrier technologies including isolators and RABS.
• Experience with lyophilization, automated loading and unloading systems, VHP/hydrogen peroxide vapor, SIP, autoclaves, depyrogenation tunnels, critical utilities, cleanrooms, and HVAC.
• Experience with commissioning, qualification, and validation using an ISPE Baseline Guide approach.
• Deep knowledge of FDA cGMP, EMA, EU Annex 1, PIC/S, and other global pharmaceutical regulations.
• Root-cause analysis skills, including FMEA and Six Sigma, plus strong verbal and written communication and stakeholder-management skills.
• Proficiency with project management software, CAD, CMMS, TrackWise/QMS, Microsoft Office, and PLC/SCADA/DCS systems.
• Must pass a background check and drug screen and be able to work in cleanroom environments with gowning.
• Ability to talk, hear, sit, stand, walk, reach, and lift up to 25–50 lbs.

Culture & Benefits

• Full-time employment with benefits eligible from the first day.
• Paid training, vacation, and holidays; vacation accrual begins on the first day.
• Career advancement opportunities, education reimbursement, and access to a learning platform.
• 401(k) program with matching contributions.
• The role provides technical leadership and matrix management but has no direct supervisory responsibilities.

Hiring process

• Apply online; unsolicited submissions from headhunters or recruitment firms are not accepted without a valid signed agreement.
• hirify.global communicates offer letters and requests for sensitive personal information only from a hirify.globalglobal.com email address.