Job Description
We are hiring a Process Engineer / Specialist to join the Tech Ops Commercial Support Process team at our Carlow site. This is an exciting opportunity to work in a biopharmaceutical manufacturing environment supporting commercial products, activities, and process improvement initiatives. The role is well suited to an experienced, independent engineer capable of acting as a technical SME and working across a wide range of stakeholders. You will have visibility across site, above site, and global teams, with opportunities to contribute to business‑critical projects, stretch assignments, and continuous development.
Role Responsibilities
Coordinate, execute and document qualification, process studies, and related product programs.
Provide technical support for commercial manufacturing, including technical impact assessments.
Own and manage change controls and related compliance commitments.
Perform data analysis using PDM/DataLynx and other relevant systems to support process understanding and decision‑making.
Use MES, PI, and automation systems to monitor, control and optimise process performance.
Conduct and support Quality Risk Assessments in line with site and corporate standards.
Support and maintain CPV and PPM systems to ensure ongoing process performance and product quality.
Ensure audit readiness, including preparation, documentation and interaction with auditors.
Generate, review and approve process documentation in line with cGMP, QMS and regulatory requirements.
Lead and support investigations, troubleshooting, and deviation resolution.
Represent Technical Operations in cross‑functional meetings and provide technical expertise as required.
Ensure compliance with QMS and relevant standards, proactively identifying and escalating compliance risks.
Drive continuous improvement using MPS / Lean tools and contribute to problem‑solving and project work.
Lead business‑critical projects and process initiatives for Technical Operations.
Demonstrate strong communication and teamwork to support a safe, compliant and high‑performing culture.
Continuously develop technical capability and provide mentoring/guidance where appropriate.
Apply understanding of key business drivers to day‑to‑day activities.
Perform other duties as required.
Qualifications and Skills Required
A Bachelor’s degree or higher in Science, Engineering, or another technical discipline.
4–5+ years’ experience in a manufacturing environment, preferably GMP, with experience in aseptic manufacturing and/or process engineering.
Demonstrated experience in:
Managing change control projects
Completing technical impact assessments on commercial products
Performing data analysis using PDM/DataLynx and presenting findings to site and global functions
Working with MES, PI, and automation systems
Supporting/leading QRA
Supporting CPV and PPM systems
Maintaining audit readiness
Strong knowledge of relevant Irish, European, and international regulatory requirements, codes and standards.
Excellent technical writing skills, including reports, standards, policies and protocols.
Familiarity with sterile filling processes and equipment.
Proficiency in Microsoft Office and other job‑related applications.
Strong communication, presentation and interpersonal skills, with the ability to work effectively across all levels and with external partners.
Experience with Lean Six Sigma methodology is preferred.
Additional Advantageous Experience
Experience with data analytics systems
Knowledge of QRM and integrated risk management
Background in fill‑finish / sterile injectables
Experience with MES / SAP and deviation management systems
Experience drafting protocols in Kneat or similar system/s
Experience in medical devices (if required skills are met)
Location: Carlow, Ireland. No relocation required. No visa sponsorship. Hybrid work arrangements. No travel required.
Recruiting agency representation is not accepted.
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