Senior Process Engineer — Aseptic Fill-Finish & Lyophilization

About the Company & Project

We are a sterile pharmaceutical compounding company building a new, state-of-the-art manufacturing facility in Houston, Texas . The facility is being developed from a Class A shell into a dual-license operation that includes both a 503B Outsourcing Facility (operating under cGMP, 21 CFR 210/211) and a 503A sterile compounding pharmacy (operating under USP <797> / <800>).

Our product lines span sterile injectables, solid oral, and nasal dosage forms , including lyophilized formulations. We are assembling an experienced engineering and operations team to bring the facility online and operate it to the highest quality and compliance standards.

This is an opportunity to join early and help build a modern sterile manufacturing operation from the ground up. (Specific product, capacity, and commercial details are shared with candidates under confidentiality during the interview process.)

The Role

This is a senior, hands-on role for an engineer who will live on-site and personally own getting our equipment and cleanrooms installed, commissioned, qualified, and shipping product . It is deliberately broad: you will work across equipment procurement, installation, commissioning, and validation rather than a single narrow slice. You will be the technical bridge between our construction team, equipment suppliers, and our quality and regulatory functions — the person who makes sure a machine specified on paper actually runs, passes qualification, and produces compliant product on our floor.

You will be one of our first engineering hires and will help shape how the facility is built and validated.

Key Responsibilities

Equipment Procurement & Vendor Coordination

• Specification & selection: Review technical specifications and user requirement specifications (URS) for fill-finish lines, lyophilizers, depyrogenation tunnels, autoclaves, water systems, and inspection/packaging equipment; support purchasing decisions and vendor selection.
• Factory acceptance testing (FAT): Coordinate with supplier engineers and travel as needed to witness FAT, ensuring equipment meets specification before it ships to Houston.
• Design review: Confirm equipment design satisfies U.S. cGMP and EU Annex 1 expectations (materials, surface finishes, sterilization, contamination control) prior to purchase.

Installation & Commissioning

• On-site installation: Manage and oversee rigging, setup, and utility hookup of process equipment, working directly with vendors and contractors on the floor.
• Site acceptance testing (SAT): Execute SAT on incoming equipment; troubleshoot and resolve startup issues so each machine performs to specification in our environment.
• Cleanroom & utility commissioning: Oversee commissioning of ISO 5/7/8 cleanrooms, HVAC/HEPA, WFI, purified water, clean steam, compressed air, and backup power.

Qualification & Validation

• IQ/OQ/PQ: Author, execute, and review installation, operational, and performance qualification protocols for equipment, utilities, and cleanrooms following ASTM E2500 and ISPE Baseline Guides.
• Aseptic process simulation: Plan and support media fills / aseptic process simulations to qualify the aseptic fill process.
• Validation lifecycle: Develop and maintain the validation master plan, qualification documentation, SOPs, and environmental monitoring program; support change control and requalification.
• Regulatory readiness: Build documentation and systems to support FDA 503B registration and inspection readiness, and USP <797>/<800> compliance on the 503A side.

Cross-Functional Leadership

• Technical bridge: Serve as the connection point between construction/GC, supplier engineers, quality/regulatory, and operations.

Required Qualifications

• Bachelor's degree in Engineering (Mechanical, Chemical, Biomedical, or related) or equivalent experience
• 7+ years of cGMP pharmaceutical or biotech engineering experience, with hands-on commissioning AND validation experience (not purely paper-based / documentation CQV)
• Demonstrated experience qualifying cleanrooms, critical utilities, and sterile process equipment (IQ/OQ/PQ)
• Working knowledge of ASTM E2500, ISPE Baseline Guides, 21 CFR Part 210/211, USP <797> and <800> , ISO 14644, and EU Annex 1
• Comfortable on the production floor during installation and startup; able to direct vendors and contractors
• Strong technical writing and documentation skills; familiarity with data integrity (21 CFR Part 11)

Preferred Qualifications

• Direct 503A/503B or sterile injectable / aseptic fill-finish experience
• Experience commissioning and integrating equipment into a U.S. cGMP site
• Lyophilization cycle development and freeze-dryer qualification experience
• Experience with isolator and RABS barrier systems and contamination control strategy (Annex 1)
• Experience bringing a greenfield sterile facility from empty shell to FDA-ready / first production
• Professional certifications (ASQ CQE/CQA, ISPE, PE) a plus

What We Offer

• The opportunity to build a sterile pharmaceutical facility from the ground up and own it end-to-end
• Competitive salary, benefits, and equity eligibility as an early team member
• High autonomy and direct impact on a fast-growing operation

How to Apply

Submit your résumé along with a short summary of the sterile facilities, fill-finish lines, and/or lyophilizers you have personally commissioned and qualified. Applications are reviewed on a rolling basis. Email View email address on click.appcast.io or apply through the job board where you found this posting.

We are an equal opportunity employer. All qualified applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status