Teams at PSC Biotech Corporation

Manage cross-functional operational and inspection readiness initiatives in a regulated life sciences environment. Coordinate action plans related to deviations, CAPAs, and process improvements; track milestones, risks, dependencies, corrective actions, and deliverables; facilitate stakeholder meetings and issue resolution; maintain dashboards and leadership reports; support gap assessments, documentation, evidence collection, and inspection preparation; and deliver project summaries and lessons learned.

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.

Leads end-to-end client software implementations, serving as the primary liaison from planning through go-live and post-launch transition. Responsibilities include managing scope, schedules, budgets, risks, documentation, validation, requirements, stakeholder coordination, training, client communications, and project closeout. The role supports regulated life sciences clients, coordinates cross-functional teams, monitors contractual deliverables, and uses project and support platforms including Wrike, JIRA, and Freshdesk. This remote East Coast contract requires travel to client sites as needed.