Jobs at PSC Biotech Corporation

Conducts biochemical and compendial QC testing under supervision, including flow cytometry, ELISA, PCR, and USP, JP, and EP analyses. Supports GMP documentation, data integrity, sample logistics, inventory, equipment maintenance, method troubleshooting, qualification activities, and OOS or deviation investigations. Maintains laboratory standards, reagents, supplies, and records while contributing to continuous improvement and following SOPs.

Develops and reviews computerized system validation plans, protocols, and reports. Performs risk assessments, impact analyses, change controls, and deviation investigations for validated systems. Ensures compliance with GxP, FDA 21 CFR Part 11, EU Annex 11, and GAMP 5. Collaborates with IT, Quality Assurance, and Manufacturing teams, maintains lifecycle documentation and traceability, and supports regulatory audits and inspections.

Leads Computer System Validation and Computer Software Assurance activities for SAP S/4HANA, SAP Cloud ALM, and related applications in regulated life sciences environments. Develops validation strategies, oversees risk assessments, testing, lifecycle deliverables, and compliance documentation for implementations, upgrades, enhancements, and ongoing support. Partners with Quality, IT, business process owners, and global project teams to ensure data integrity, system reliability, and GxP compliance.

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.

Lead biopharma operational-readiness projects by developing execution strategies, integrated schedules, risk registers, and cross-functional workstreams. Coordinate construction, commissioning, qualification, validation, manufacturing launch, technology transfer, and new product introduction activities. Facilitate meetings and workshops, resolve issues, manage risks, communicate status to leadership, and drive alignment across stakeholders while ensuring regulatory compliance and site readiness.

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%.

Engineering Interns support equipment, facilities, and utility projects in a GMP-regulated pharmaceutical manufacturing environment. Responsibilities include engineering documentation, data collection, equipment installation and troubleshooting support, maintenance, validation activities, performance trending, and continuous improvement. Interns collaborate with Engineering, Validation, Quality, and Operations teams while following safety, GMP, and quality procedures. The role requires an ongoing part-time schedule during academic semesters and is based locally in York, Pennsylvania.

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.

Manage end-to-end recruitment for consulting projects, including gathering requirements, sourcing internal and external candidates, screening applicants, coordinating interviews, facilitating offers, and advising on rates and work-pass requirements. Maintain candidate databases, CV folders, resource allocation records, trackers, and recruitment documentation. Prepare weekly recruitment reports and meeting minutes while supporting project managers and leadership with resource availability and candidate submissions.

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.

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.

Performs aseptic and non-aseptic pharmaceutical manufacturing operations, including equipment preparation, CIP/SIP, compounding, filtration, formulation, filling, cleaning, sanitization, and documentation. Maintains aseptic gowning certification and GMP compliance, supports investigations, validation, commissioning, and deviation reporting, and collaborates with engineering, warehouse, and facilities teams.

Performs aseptic and non-aseptic pharmaceutical manufacturing operations, including equipment preparation, cleaning, formulation, compounding, filtration, and filling. Completes GMP documentation, maintains aseptic gowning certification, supports investigations, validation, sanitization, and sterilization activities, and assists engineering, warehouse, and facilities teams. Level II responsibilities include authoring SOPs and batch records, supporting process formulation and validation, managing floor inventory, and training Manufacturing Associate I employees.

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.

Leads end-to-end CDMO operations across sterile injectable manufacturing, quality, supply chain, logistics, customer execution, and business development. Ensures GMP and regulatory inspection readiness, operational scalability, capacity planning, continuous improvement, risk mitigation, business continuity, and P&L performance. Partners with customers, suppliers, department heads, and the CEO to achieve reliable delivery, quality, compliance, financial targets, and sustainable growth while building a high-performing manufacturing organization.

Performs microbiological and environmental monitoring testing for product release in a cGMP pharmaceutical environment. Responsibilities include sample testing, data review, LIMS documentation, trend reporting, method qualification and validation, contamination investigations, equipment maintenance, SOP updates, audit support, analyst training, sample lifecycle management, and laboratory inventory coordination. The role also supports continuous improvement, process compliance, safety, and manufacturing operations.

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.

Performs aseptic and non-aseptic pharmaceutical manufacturing operations, including equipment preparation, compounding, formulation, filtration, filling, cleaning, sanitization, documentation, and validation. Maintains GMP, FDA, EU, ISO, and aseptic standards; investigates deviations; authors controlled documents; supports process validation and tech transfer; manages floor inventory and schedule changes. Level III associates lead manufacturing teams, assist with investigations and corrective actions, train junior associates, and coordinate with QA, QC, Engineering, R&D, and Validation.