Validation & Process Engineer (Sterile Operations)

Validation & Process Engineer (Sterile Operations)

Location:

Near Schenectady, NY (On-site)

Company:

Rx relief

Employment Type:

Full-Time, 503B Outsourcing The Opportunity Rx relief is currently partnering in a high-growth launch phase, preparing a state-of-the-art facility for commercial sterile compounding. We are looking for a Validation & Process Engineer to serve as a technical cornerstone of their operations. In this role, you won't just be following a script—you will be the architect of their validation lifecycle, ensuring their ISO-classified environments and high-tech manufacturing systems exceed FDA and USP benchmarks from day one. The Impact You Will Make As they move toward production, you will bridge the gap between engineering design and regulatory compliance. You will be responsible for the "readiness" of the facility, ensuring every piece of equipment and every chemical process is qualified, repeatable, and audit-proof. Primary Scope of Work 1. Systems Qualification & Validation Lifecycle Design and execute comprehensive qualification strategies (IQ/OQ/PQ) for critical plant utilities, including WFI, purified water, clean steam, and HVAC. Take point on process validation for sterile fill-finish, aseptic filtration, and terminal sterilization cycles. Oversee the commissioning of new manufacturing hardware, from initial FAT/SAT through to final production turnover. Manage Computer System Validation (CSV) for our digital ecosystem (MES, ERP, and QMS) in alignment with 21 CFR Part 11. 2. Manufacturing Architecture & Optimization Define and refine compounding workflows, including API dissolution and 0.2 um filtration protocols. Draft and maintain technical engineering blueprints, including P&IDs and process flow diagrams. Lead risk management initiatives using FMEA and HACCP to proactively identify quality bottlenecks. Utilize Lean and Six Sigma tools to drive operational efficiency and resolve process deviations via root cause analysis. 3. Facility Integrity & Compliance Maintain the gold standard for our ISO 5, 7, and 8 cleanrooms through rigorous smoke studies, pressure differential checks, and HEPA integrity testing. Act as the Engineering SME during FDA inspections and state-level audits. Ensure all technical documentation adheres to ALCOA+ data integrity standards and remains in a constant state of "audit-readiness." What You Bring to the

Team Education:

A degree in Chemical, Mechanical, or Pharmaceutical Engineering (or a related technical field).

Experience:

2-5 years in a regulated cGMP environment (Pharma, Biotech, or 503B).

Technical Literacy:

Proven success in authoring validation protocols and managing the equipment lifecycle.

Regulatory Knowledge:

Familiarity with 21 CFR 210/211 and a desire to master USP / standards.

Mindset:

A "builder" mentality—you enjoy high-stakes startup environments where documentation discipline is paramount.

Bonus Points For:

Direct experience with 503B sterile compounding. Six Sigma Green Belt or similar process improvement credentials. Fluency in Spanish. Why Join Rx relief?

Pioneering Role:

Be part of the foundational team that brings a new facility online.

Advanced Tech:

Work with digital-first production systems and modern cleanroom suites.

Total Rewards:

Competitive base salary, comprehensive medical/dental/vision, 401(k) matching, and generous PTO.

Professional Evolution:

We support your growth through conference attendance and continuing education.

Compensation / Pay

Rate (Up to): $135,000.00 - $185,000.00 Per Year