Jobs at PCI Pharma Services

Serves as a senior legal advisor to commercial, procurement, finance, and operations teams. Drafts, reviews, and negotiates complex commercial agreements, leads high-value contract negotiations, manages legal and commercial risk, and improves contracting processes, templates, playbooks, and lifecycle tools. Advises on pricing, liability, indemnification, intellectual property, privacy, compliance, and regulatory matters. Mentors junior legal professionals and supports dispute resolution and broader legal initiatives.

Manage New Product Introduction projects for PCI Pharma Services Ireland, overseeing planning, timelines, resources, risks, governance, client communication, and project closure. Lead internal and external kickoff meetings, monitor critical paths, coordinate cross-functional teams, report project status, support continuous improvement, and ensure compliance with safe work practices. The role requires collaboration across business functions and direct engagement with biopharmaceutical clients.

Supports engineering leads with new product introduction projects from business development handover through equipment qualification and operational handover. Responsibilities include URS development, design reviews, FAT and SAT support, commissioning, IQ/OQ/PQ activities, project tracking, vendor coordination, GMP documentation, change control, SOP updates, equipment readiness, and continuous improvement. The graduate will develop expertise in regulated pharmaceutical packaging and device assembly equipment while building project management and cross-functional collaboration skills.

Manage R&D documentation, controlled records, forms, templates, databases, reports, and process monitoring charts in a pharmaceutical development environment. Support change controls, protocol and report preparation, training records, personnel administration, procurement, shipments, and data collection while maintaining cGMP compliance, data integrity, traceability, and document control. Collaborate with R&D, Quality, Supply Chain, Operations, HR, Purchasing, and project teams, and identify process improvements.

Coordinates quality activities for biopharmaceutical production teams. Reviews completed order documentation for cGMP and customer compliance, creates and updates batch records and specifications, manages approvals, submits release documentation, resolves document issues, provides quality metrics, and performs finished-product batch release. The role requires detailed technical documentation review, customer communication, adherence to quality procedures, and occasional overtime or weekend work.

Manages quality engineering throughout product transfer and commercial operations in an FDA-regulated biopharmaceutical manufacturing environment. Responsibilities include validation, sampling plans, control plans, FMEA, process capability analysis, root cause investigations, CAPA, supplier quality, nonconforming product disposition, technical documentation, audits, and continual process improvement. Collaborates with customers, suppliers, engineering, manufacturing, procurement, and validation teams while supporting medical device and combination product programs.

Oversee site-wide calibration, maintenance, and compliance of measuring equipment in a pharmaceutical environment. Perform complex calibrations, analyze and trend data, investigate failures, improve procedures, support equipment studies, coach process owners, maintain metrology standards, and coordinate calibration contractors. Ensure adherence to GxP, FDA, NIST, ISO, and site requirements while supporting continuous improvement and troubleshooting.

Owns the global Record to Report finance process across business units, including standardization, governance, JDE ERP configuration, requirements gathering, testing, UAT, training, and change adoption. Leads ERP transformation in partnership with finance leaders, regional teams, and system integrators. Designs system-enabled financial controls supporting SOX 404 readiness, external audits, regulatory reporting, financial close, consolidation, and global process harmonization.

Manages clinical drug supply strategies and materials across Phase I–IV and complex global studies. Responsibilities include protocol interpretation, supply planning, packaging and labeling coordination, IRT setup and testing, inventory and shipment tracking, depot and site management, import/export and quality support, risk resolution, temperature excursion adjudication, budget management, drug accountability, and cross-functional client communication. Ensures compliance with PCI, cGMP, and GCP requirements.

Oversee supplier quality management for GMP operations, including supplier audits, audit report issuance, corrective-action tracking, change notifications, nonconformance and complaint handling, quality agreements, metrics reporting, SOP management, regulatory inspection support, and continuous improvement. Work independently with cross-functional teams and support FDA compliance activities across PCI facilities.

Leads site sterility assurance and contamination-control programs in an aseptic production environment. Oversees environmental monitoring, media fills, aseptic process simulations, cleaning and disinfection, audits, deviations, CAPAs, risk assessments, data trending, and inspection readiness. Develops Quality team expertise, supports regulatory agency discussions, and provides leadership across all production shifts while ensuring compliance with global pharmaceutical regulations.

Leads environmental, health, and safety programs across assigned PCI sites and regions. Partners with site leadership to ensure regulatory compliance, conduct audits, assess risks, investigate incidents, manage environmental and industrial hygiene requirements, deliver training, and improve safety culture. Provides technical EHS expertise, supports inspections, oversees corrective actions, and leads management-system implementation and continuous improvement. Requires international travel and occasional extra hours or weekend work.

Expedites tooling, parts, supplies, equipment, and documentation to maintenance and operations teams. Responsibilities include staging and inspecting tooling, delivering carts and hardware, maintaining accurate CMMS inventory and locations, updating bills of materials, assembling or repairing tooling, creating replacement purchase orders, and performing cycle counts. The role also resolves tooling issues with maintenance and engineering personnel and follows PCI, cGMP, and GCP procedures.

Leads a multi-shift mechanical maintenance organization supporting 24/7 pharmaceutical manufacturing. Oversees managers and reliability supervisors, workforce planning, union relations, preventive and predictive maintenance, reliability programs, root cause analysis, inventory, budgets, KPIs, safety, compliance, and continuous improvement. Partners cross-functionally on equipment installation, capital projects, training, and operational performance while driving uptime, cost savings, labor productivity, and equipment reliability.

Supports business development executives through account management, client meeting preparation, meeting minutes, lead generation, outbound prospecting, CRM updates, client follow-up, trade show support, site visit coordination, and smaller account management. Researches biopharma, medical device, animal health, and cell and gene therapy companies, identifies contacts, supports marketing campaigns, and coordinates legal documentation with internal and client legal teams.

Leads Quality Control operations across a biopharmaceutical development and manufacturing campus. Oversees cGMP testing, investigations, CAPA, method lifecycle management, regulatory inspections, client relationships, laboratory expansion, budgets, suppliers, and operational excellence initiatives. Partners with Manufacturing, MSAT, Validation, and Quality Assurance to support product quality and business growth. Builds and manages multidisciplinary QC leadership and technical teams across multiple sites.

Manages customer packaging and pharmaceutical service projects from planning through completion, ensuring timelines, budgets, deliverables, regulatory compliance, and customer expectations are met. Serves as the primary customer contact, leads project teams and kickoffs, manages expenses, billing, specifications, contracts, pricing, and contribution margins, and supports business development. Coaches Associate Project Managers, coordinates customer visits, facilitates lessons learned, and contributes to continuous improvement and employee onboarding.

Manages customer packaging projects from planning through completion, overseeing timelines, budgets, contracts, specifications, pricing, billing, compliance, communication, and client satisfaction. Leads project teams and kickoff meetings, facilitates business reviews and lessons learned, supports business development, mentors associate project managers, manages customer visits, and contributes to continuous improvement while adhering to PCI, cGMP, and GCP requirements.

Supports pharmaceutical customer projects and order fulfillment by managing production schedules, forecasts, procurement requisitions, ERP and MRP workflows, material inventory, documentation, quality releases, shipment preparation, and delivery metrics. Coordinates with customers, procurement, quality, production, and project teams to resolve issues, maintain compliance with cGMP and GCP requirements, manage obsolete materials, and ensure timely completion within budget and schedule.

Manage end-to-end New Product Introduction programs in a pharmaceutical CDMO environment from award through commercialization. Coordinate cross-functional Engineering, Quality, Operations, Procurement, Supply Chain, and Validation teams; maintain schedules, RAID logs, budgets, and project documentation; manage stage gates, technology transfer, validation, manufacturing readiness, regulatory milestones, and client communications. Escalate risks and scope changes, support capital expenditure tracking, and contribute to continuous improvement of NPI processes.