Jobs at PSC Biotech Corporation

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.

Leads regional business operations, business development, consulting proposals, employee hiring and performance management, and billable project execution. Provides technical expertise in equipment and process validation, maintains project profitability, develops client relationships within the life sciences industry, and supports regional growth across Australia. Requires substantial biotech experience, strong leadership and project management capabilities, and travel up to 25%.

Leads operational readiness for capital projects, transitioning facilities, utilities, equipment, and systems into routine operations. Responsibilities include design reviews, maintenance and reliability planning, CMMS/SAP setup, commissioning, qualification, validation, risk analyses, HAZOPs, FAT/SAT, IQ/OQ/PQ, documentation, training, and operational handover. The role coordinates engineering, project, maintenance, and operations stakeholders in a regulated manufacturing environment.

Supports commissioning, qualification, and validation of pharmaceutical fill-finish facilities, utilities, and equipment in GMP manufacturing environments. Responsibilities include controlled documentation, equipment qualification, risk analyses, design reviews, FAT/SAT, IQ/OQ/PQ execution, filling-line integration, MES recipe startup and debugging, project tracking, and stakeholder coordination. The role requires hands-on cleanroom experience with vial filling and aseptic processing systems, plus strong technical writing and project management skills.

Commission, qualify, and validate pharmaceutical facilities, utilities, equipment, and water systems. Develop and execute CQV protocols, reports, SOPs, and quality documentation while supporting DQ, FAT, SAT, IQ, OQ, PQ, and PV activities. Conduct risk assessments, design reviews, pressure testing, flushing, passivation, sanitization, and lifecycle management for PW and WFI systems. Collaborate with clients, contractors, vendors, and cross-functional teams while ensuring compliance with cGMP and 21 CFR requirements.

Leads commissioning, qualification, and validation activities for GMP-regulated systems, facilities, and equipment. Authors and executes DQ, FAT, SAT, IQ, OQ, PQ, and PV documentation; develops SOPs, validation reports, and quality policies; supports temperature mapping and autoclave qualification; coordinates project timelines and stakeholders; and ensures compliance with cGMP, regulatory standards, and quality systems.

Deliver capital engineering projects across design, procurement, installation, commissioning, qualification, and validation. Manage project scope, schedules, budgets, risks, technical documentation, and stakeholder coordination while ensuring GMP and regulatory compliance. Execute FAT, SAT, IQ, OQ, and PQ activities; prepare controlled documents and technical specifications; support audits, inspections, and regulatory interactions. The role also requires stakeholder management, communication, problem-solving, and experience with packing lines and risk-based CQV approaches.