Senior Process Engineer – ContractLocation:Carlow, Ireland (On-site)Role Summary-The Senior Process Engineer will provide process engineering support for upgrade projects within an existing sterile filling facility. The role involves working closely with cross-functional teams to deliver new and upgraded process equipment and systems. Acting as thePackage OwnerandVendor Point of Contact, the successful candidate will ensure equipment and processes meet operational, regulatory, and business requirements.Key Responsibilities-Project & Equipment OwnershipServe as Package Owner for new and existing process equipment upgrades.Manage vendors throughout the lifecycle — from detailed design, fabrication, installation, and site delivery through to PQ completion.Develop and review key process documentation, including Process Flow Diagrams (PFDs), P&IDs, User Requirement Specifications (URS), and Equipment Specifications.Ensure all process safety deliverables are completed, including Process Hazard Analyses (HAZOPs).Ensure all design work aligns with company engineering standards, procedures, and best practices.Cross-Functional CollaborationWork as part of an integrated project team to ensure stakeholder inputs are captured and reflected in design and execution.Coordinate with project stakeholders to align milestones, monitor progress, and report on key deliverables and status.Collaborating with CQV (Commissioning, Qualification, and Validation) leads to support documentation, testing, and qualification phases.Lifecycle & Validation SupportDevelop and/or review lifecycle documents, including risk assessments, FAT documentation, and C&Q documentation.Support equipment installation, start-up, and testing through to OQ completion, ensuring readiness for PQ and PPQ phases.Liaise with internal and external stakeholders, including vendors, SMEs, and project partners across multiple locations.Project ManagementMay support general project engineering duties such as scheduling, work planning, and equipment cost tracking.Qualifications & Experience-Bachelor's or Master's Degree in Chemical, Biochemical, or related Engineering discipline.Minimum of 5 years' post-graduate experience in process engineering within the pharmaceutical or biopharmaceutical industry.Experience in aseptic/sterile processing design, construction, and start-up is highly desirable.Proven ability to lead and influence within cross-functional or matrix teams.Strong communication, presentation, and organizational skills.Deep understanding of formulation and filling operations and associated process technologies.Familiarity with SDLC methodology and project execution in a GMP environment.