Senior Process Engineer – Contract
Location:
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 the
Package Owner
and
Vendor Point of Contact
, the successful candidate will ensure equipment and processes meet operational, regulatory, and business requirements.
Key Responsibilities-
Project & Equipment Ownership
* Serve 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 Collaboration
* Work 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 Support
* Develop 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 Management
* May 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.