Principal Engineer

Principal Engineer - Filling & Lyophilization - United States

Build your future at Curia, where our work has the power to save lives.

The Principal Engineer will lead equipment engineering for large capital projects in sterile filling and lyophilization to support Curia's strategic growth. This includes leading network-wide capital execution to expand, modernize, and standardize manufacturing infrastructure. The incumbent will direct the specification, procurement, installation, commissioning, and qualification of advanced aseptic technologies to increase capacity, efficiency, and compliance for drug product programs. This position interfaces with Curia's network manufacturing sites, client technical teams, and global leadership. The role provides technical oversight, mentorship, and engineering guidance across site-based teams and major capital project teams.

Curia is a global contract development and manufacturing organization (CDMO) with over 30 years of experience partnering with pharmaceutical and biotech companies to provide life-saving treatments to patients. At Curia, we are on a mission to advance our customers' therapies from curiosity to cure and ultimately to improve patients' lives.

We proudly offer

• Generous benefit options (eligible first day of employment)
• Paid training, vacation and holidays (vacation accrual begins on first day of employment)
• Career advancement opportunities
• Education reimbursement
• 401K program with matching contributions
• Learning platform
• And more!

Responsibilities

• Capital Project Execution: Lead filling and lyophilization equipment engineering for major capital projects ($10M-$50M+) from conceptual design through Commissioning, Qualification, and Validation (CQV)
• Technical Transfer & Client Support: Drive robust, on-time technical transfers of API and Drug Product (DP) programs, partnering with the Global Program Management Office and site technical operation teams to satisfy client expectations
• Equipment Specification & Procurement: Author User Requirement Specifications (URS), drive vendor selection, conduct capital cost estimation, and lead Factory/Site Acceptance Testing (FAT/SAT) for primary equipment (fill lines, isolators, lyos, VHP, capping)
• Network Capability & Talent Development: Mentor site-based engineering teams across the Curia network, sharing best practices, upgrading skill sets, and driving technical standardization
• Operational Excellence & Continuous Improvement: Partner with sites to troubleshoot complex equipment deviations, increase OEE, reduce cycle times, and execute cost-improvement programs
• Vendor & Engineering Firm Management: Oversee external engineering design firms, equipment vendors, and field contractors for filling and lyophilization installations
• Regulatory Compliance: Ensure all equipment and system designs comply with cGMP, EU Annex 1 (Contamination Control Strategy), FDA guidance, and global regulatory standards
• This job has no direct supervisory responsibilities; serves as a technical lead and matrix manager for project teams and site engineering resources
• Travel Requirement: Up to 25% travel, including international travel to plant sites and vendor facilities

Education and Experience

• Education: BS in Mechanical, Chemical, Electrical, or Biomedical Engineering (or related discipline)
• Experience: Minimum 10+ years of pharmaceutical engineering experience in sterile drug product manufacturing or CDMO technical operations
• Capital Projects: Proven track record leading major capital equipment execution projects exceeding $10M

Technical Expertise: Advanced expertise in

• Aseptic processing, high-speed sterile filling (vials, syringes, cartridges), and barrier technology (Isolators/RABS)
• Lyophilization processes and automated loading/unloading systems (ALUS)
• Decontamination systems (VHP / Hydrogen Peroxide Vapor)
• Sterilization processes (SIP, Autoclaves, Depyrogenation Tunnels)
• Critical Utilities (WFI, Clean Steam, Clean Compressed Air, Process Gases, Cleanrooms, and HVAC)
• Commissioning, Qualification, and Validation (CQV / ISPE Baseline Guide approach)
• Regulatory & Quality Knowledge: Deep understanding of global pharmaceutical regulations (FDA cGMP, EMA, EU Annex 1, PIC/S)

Skills & Capabilities

• Analytical & Problem Solving: Demonstrated root-cause analysis skills (e.g., FMEA, 6-Sigma) to address complex process and equipment deviations
• Communication & Stakeholder Management: Excellent verbal and written communication skills with experience presenting technical concepts to executive leadership, site teams, and external clients
• Computer & Software Skills: Proficient in project management software, CAD systems, CMMS, Trackwise/QMS systems, MS Office Suite (Word, Excel, PowerPoint), and process automation systems (PLC/SCADA/DCS)

Other Qualifications & Requirements

• Must pass a background check and drug screen
• Ability to work in cleanroom environments (Gowning required)

Physical Demands & Work Environment

• Physical Demands: Regularly required to talk, hear, sit, stand, walk, reach, and lift up to 25-50 lbs
• Work Environment: Mix of office environment, active construction sites, and cGMP cleanrooms. Moderate noise level with exposure to moving mechanical parts and industrial chemical/utility systems

This job description in no way states or implies that these are the only duties to be performed by the employee(s) incumbent in this position. Employees will be required to follow any other job-related instructions and to perform any other job-related duties requested by any person authorized to give instructions or assignments. All duties and responsibilities are essential functions and requirements and are subject to possible modification to reasonably accommodate individuals with disabilities. To perform this job successfully, the incumbents will possess the skills, aptitudes, and abilities to perform each duty proficiently. Some requirements may exclude individuals who pose a direct threat or significant risk to the health or safety of themselves or others. The requirements listed in this document are the minimum levels of knowledge, skills, or abilities. This document does not create an employment contract, implied or otherwise, other than an "at will" relationship.

Salary range:$120,200-$144,100/year

Education, experience, location and tenure may be considered along with internal equity when job offers are extended.

We do not accept unsolicited assistance from any headhunters or recruitment firms for any of our job openings. All resumes or profiles submitted by search firms to any employee at Curia, in any form without a valid, signed search agreement by an authorized signatory in place for the specific position, approved by Talent Acquisition, will be deemed the sole property of Curia. No fee will be paid in the event the candidate is hired by Curia because of the unsolicited referral.

All interested applicants must apply online. Please be aware of scammers. Curia will only send offer letters and requests for sensitive personal information from a curiaglobal.com email address. Curia is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Curia is an E-Verify employer.

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