Jobs at PSC Biotech Corporation

Performs aseptic and non-aseptic pharmaceutical manufacturing operations, including equipment preparation, compounding, formulation, filtration, filling, cleaning, sanitization, sterilization, and documentation. Leads manufacturing teams, supports investigations and validation, authors controlled documents, assists with process development, and trains junior associates. Requires sterile injectable experience, strong aseptic technique, GMP compliance, variable-shift availability, and the ability to manage floor activities in a supervisor’s absence.

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.

Maintain accounts receivable and payable, billing, collections, payment controls, reconciliations, general ledger integrity, month-end close, payroll accounting, VAT records, audit schedules, and financial reporting. The role also supports accounting systems, finance transitions, process improvements, and compliance with Irish and UK requirements. This is a full-time remote position based in the Philippines supporting Ireland and UK finance operations.

Manage full commissioning, qualification, and validation (CQV) lifecycle projects for pharmaceutical clients. Responsibilities include project planning, scheduling, budgeting, risk mitigation, regulatory compliance, stakeholder communication, and vendor or contractor coordination. The role applies risk-based CQV methodologies, supports project initiation through closure, and requires strong analytical, problem-solving, quality, and compliance skills. Travel may be required for client assignments and project engagements.

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.

Lead end-to-end commissioning, qualification, and validation projects for pharmaceutical manufacturing facility expansions, upgrades, and capacity increases. Manage project planning, scheduling, budgets, risks, stakeholders, vendors, and contractors while ensuring GMP compliance, product quality, regulatory adherence, and complete validation documentation across the CQV lifecycle.

Provides Quality Assurance oversight for pharmaceutical, biotechnology, or medical-device validation documentation. Reviews and approves validation protocols, reports, risk assessments, deviations, investigations, CAPAs, and change controls. Ensures compliance with GMP, FDA, EU GMP, ICH, company procedures, and document-control requirements. Collaborates with Validation, Engineering, Manufacturing, and Quality teams to resolve deficiencies, supports audit and inspection readiness, and contributes to quality-system improvements.

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.

Supports aseptic manufacturing, technology transfer, process validation, equipment qualification, lyophilization, investigations, and continuous improvement for sterile injectable CDMO operations. Leads process characterization, PPQ, media fills, contamination control, audit support, and manufacturing troubleshooting while collaborating with Quality, Validation, Facilities, Supply Chain, and client teams.

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.

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.

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.

Open application for future technical internships at a sterile injectable pharmaceutical CDMO. Interns may support engineering, validation, quality, facilities, maintenance, metrology, robotics, analytical laboratories, manufacturing, or business development. Candidates should be pursuing a related technical degree, demonstrate analytical, communication, teamwork, problem-solving, and organizational skills, and be available for ongoing part-time work during academic semesters. Applicants must live near York, Pennsylvania and be authorized to work in the United States.

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.

Performs quality control microbiology testing, environmental monitoring, disinfectant efficacy testing, and bioburden and endotoxin assays in a GMP-regulated sterile injectable manufacturing environment. Maintains data integrity, supports method validation, investigations, contamination control, trend analysis, and regulatory compliance. Authors technical documentation, operates laboratory equipment, mentors junior staff, and leads complex testing and validation projects.

Provides administrative and operational support across Human Resources and Talent Acquisition for a seven-month temporary contract. Responsibilities include onboarding and offboarding, maintaining confidential HR records and HRIS data, supporting benefits and employee inquiries, preparing reports, coordinating meetings and events, tracking training documentation, assisting with audits and projects, and serving as a responsive contact for employees, candidates, and stakeholders.