Teams at PSC Biotech Corporation

Supports commissioning, qualification, and validation of pharmaceutical and biomedical facilities, utilities, and equipment. Authors and executes DQ, FAT, SAT, IQ, OQ, PQ, and PV documentation; develops SOPs and validation reports; performs risk analyses and design reviews; ensures cGMP, GDP, and data integrity compliance; coordinates vendors, contractors, and cross-functional teams; manages project activities, timelines, and status reporting; and mentors clients and junior engineers.

Provides technical leadership for pharmaceutical process development and manufacturing projects in a GMP-regulated environment. Defines process requirements, supports equipment and system design, technology transfer, commissioning, qualification, validation, risk assessments, troubleshooting, investigations, and continuous improvement. Partners with project, operations, quality, and engineering teams to ensure compliant process integration and operational readiness. Authors and executes validation documentation, develops SOPs and CQV protocols, and supports manufacturing technologies including pre-filled syringes, vial filling, sterile filtration, bulk product, NPI, and plasma manufacturing.

Provides Quality Assurance oversight for pharmaceutical, biotechnology, medical device, and regulated-industry projects. Reviews GMP documentation, supports commissioning, qualification, validation, technology transfer, process lifecycle, vendor qualification, and capital projects. Manages deviations, investigations, change controls, CAPAs, risk assessments, audits, and inspections while ensuring cGMP, GxP, and global regulatory compliance.