Jobs at PSC Biotech Corporation

Leads engineering projects in regulated life sciences manufacturing from requirements and design through procurement, installation, commissioning, qualification, and closeout. Coordinates Manufacturing, Quality, Validation, Automation, Facilities, EHS, contractors, and vendors while managing scope, schedules, budgets, documentation, GMP compliance, change control, risk, and safety. Supports equipment startup, troubleshooting, operational readiness, system turnover, and improvements to reliability, efficiency, compliance, and project execution.

Leads the Quality function across sterile injectable manufacturing, including QA, QC, compliance, validation, cleanroom operations, audits, inspections, CAPA, deviations, supplier quality, and change controls. Manages teams and consultants, provides floor-level quality oversight, mentors staff, supports regulatory readiness, and advises Business Development, MSAT, sponsors, and client programs on quality strategy and compliance.

Supports commissioning, qualification, and validation of pharmaceutical and biotechnology facilities, utilities, equipment, and manufacturing systems. Develops and executes IQ/OQ/PQ protocols, validation plans, risk assessments, traceability matrices, and reports. Performs system walkdowns, investigates discrepancies, supports CAPA and change controls, and coordinates with engineering, manufacturing, quality, automation, and facilities teams to ensure cGMP compliance. Travel to client sites is required as needed.

Supports validation and compliance for computerized systems in regulated life sciences environments. Develops and reviews CSV lifecycle documentation, executes IQ/OQ/PQ and UAT testing, performs risk assessments, evaluates data integrity and electronic records compliance, and supports change controls, deviations, CAPA, audits, inspections, implementations, upgrades, and validated-state maintenance.

Supports post-market quality activities for medical devices by reviewing complaints, assessing MDR reportability and patient safety impact, preparing regulatory reports, supporting investigations, maintaining eQMS records, and contributing to surveillance, trending, and compliance initiatives. Collaborates with Quality, Regulatory, Engineering, Manufacturing, and Clinical teams while ensuring adherence to FDA regulations, ISO standards, and internal quality systems.

Leads commissioning, qualification, and validation projects for pharmaceutical and biotechnology manufacturing environments. Manages multidisciplinary teams, schedules, budgets, validation protocols, documentation, risks, contractors, and regulatory compliance. Coordinates facility, utility, equipment, automation, and process implementation activities from project initiation through operational readiness and closeout, using Kneat Gx digital validation systems.

CQV and Validation Engineers support pharmaceutical and biotechnology manufacturing projects through commissioning, qualification, and validation of facilities, utilities, equipment, automation, and processes. Responsibilities include protocol development, field execution, discrepancy resolution, documentation, project coordination, startup support, and audit readiness within GMP environments. Multiple levels are available, from entry-level to senior professionals. Prior Kneat Gx experience is required.

Provides Quality Assurance oversight for pharmaceutical and regulated-industry commissioning, qualification, validation, technology transfer, manufacturing, capital projects, vendor qualification, and quality systems. Reviews and approves GMP documentation, supports deviations, investigations, change controls, CAPAs, and risk management, and ensures compliance with global regulatory requirements. Collaborates with cross-functional teams, supports audits and inspections, and contributes to continuous improvement.

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.

Temporary three-month manufacturing internship supporting sterile injectable pharmaceutical production. Performs aseptic and non-aseptic filling, equipment preparation, CIP/SIP operations, compounding, filtration, formulation, documentation, room sanitization, deviation reporting, validation, and GMP-compliant manufacturing activities. Provides cross-functional support to engineering, warehouse, and facilities teams while maintaining aseptic technique and quality standards.

Performs aseptic and non-aseptic pharmaceutical manufacturing operations, including equipment preparation, cleaning, compounding, filtration, formulation, filling, room sanitization, documentation, and validation activities. Maintains aseptic gowning and GMP compliance, investigates deviations, and supports engineering, warehouse, and facilities teams. Requires a high school diploma, manufacturing experience, mechanical aptitude, strong attention to detail, and flexibility for extended and rotating shifts.

Provides administrative and operational support for global HR initiatives, including compliance tracking, policy and handbook coordination, SOP documentation, project tracking, reports, communications, meetings, town halls, and file management. Coordinates with US-based and global stakeholders in a fully remote role supporting US HR operations during overnight Philippines hours.

Leads sterile injectable formulation development, compounding process design, technology transfer, scale-up, process characterization, and commercial manufacturing readiness. Provides technical support for aseptic filling, sterile filtration, lyophilization, engineering runs, deviations, batch investigations, and validation. Collaborates with clients, Manufacturing, Quality, Validation, Engineering, and Regulatory teams. Develops transfer plans, risk assessments, process documentation, and manufacturing instructions while ensuring compliance with FDA cGMP, EU GMP Annex 1, ICH, and USP standards.

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%.

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.

Owns full-cycle business development and quota attainment for professional services across validation, quality, engineering, and related life sciences disciplines. Identifies and closes new opportunities, expands assigned accounts, manages pipelines and forecasts, conducts market research, builds client relationships, and supports customer satisfaction and retention. The role requires consultative selling, cross-functional collaboration, industry event participation, and travel.