Job description

Process Engineer

Position Overview:

The Process Engineer will lead process improvement and validation activities across the manufacturing site to ensure robust, efficient, and compliant production. Working cross-functionally with operations, quality, maintenance, and supply chain, the role will design, optimise, validate, and sustain processes that meet productivity targets, quality standards, regulatory requirements, and safety expectations. The successful candidate will own continuous improvement roadmaps, drive data-led problem solving, and ensure changes are validated and effectively controlled through the site’s quality systems.
Compliance with ISO 13485: Steripack Ireland adherence to ISO 13485 standard, including the responsibility for maintaining and improving the quality management system. All employees shall contribute to this aspect where reasonable and depending on the scope of the position responsibilities.
Documentation and Record Keeping: The creation, maintenance, and management of quality-related documents and records is an aspect of all employees. Adherence to document best practices as described in internal procedures are critical towards adherence to ISO 13485 standard.
Effective communication with other departments, management, and regulatory authorities regarding quality issues and compliance with ISO 13485 is an aspect where reasonable and depending on the scope of the position responsibilities.

Key Responsibilities:

Involved in the day to day operations of the Engineering function, including but not limited to:

Process Improvement & Optimisation: Identify and implement improvements to cycle time, yield, scrap, and OEE using Lean/Six Sigma methods (e.g., DMAIC, Kaizen, SPC).
Validation Ownership: Plan and execute IQ/OQ/PQ for equipment, processes, and changes; maintain validation master plans, protocols, and reports in accordance with site procedures and regulatory requirements.
Lead root cause investigations (e.g., 5-Why, Fishbone, DOE) and implement sustainable corrective/preventive actions (CAPA).
Documentation & Change Control: Generate and maintain SOPs, work instructions, PFMEA/Control Plans; manage changes through the site change control process.
Data & Metrics: Define and monitor process KPIs; analyse performance trends; present technical findings and improvement actions to stakeholders.
Scale-Up & Transfers: Support new product/process introductions, technology transfers, and equipment upgrades, ensuring process capability and validation readiness.
Risk & Compliance: Ensure processes meet EHS, quality, and regulatory standards; participate in audits and support responses/actions.
Cross-Functional Collaboration: Partner with Production, Quality, Maintenance, R&D/Engineering, and Supply Chain to deliver on-time, right-first-time outcomes.
Training & Coaching: Provide training for operators/technicians on new processes or changes; coach teams in basic CI/validation principles.
Vendor/Equipment Liaison: Work with suppliers on equipment selection, FAT/SAT, and performance acceptance criteria.

Qualifications, Knowledge & Skills:

Qualifications:
Required (Compliance-Oriented):

Bachelor’s degree (NFQ Level 8 or equivalent) in Mechanical, Manufacturing, Process, Chemical, or Biomedical Engineering (or closely related discipline).
Demonstrated competence in process validation (IQ/OQ/PQ) and change control within a regulated manufacturing environment (e.g., ISO 9001, ISO 13485, EU GMP/HPRA, or similar).

Knowledge:

Strong understanding of process validation (VMP, URS, risk assessment, IQ/OQ/PQ), statistical methods, and process capability (Cp/Cpk).
Familiarity with quality systems (SOPs, CAPA, deviations, change control), PFMEA/Control Plan, and audit readiness.
Knowledge of Lean/Six Sigma tools, SPC, DOE, and problem-solving methodologies.
Awareness of EU regulatory frameworks relevant to the site (e.g., ISO 9001; where applicable, ISO 13485 for medical devices or EU GMP/HPRA for pharma/combination products).
Understanding of EHS principles, risk assessments, and safe systems of work.
Systems know-how: MES/ERP, eQMS, data analysis/visualisation tools (e.g., Excel/Power BI), and equipment data logging/SCADA.

Skills:

Strong analytical and statistical skills with the ability to translate data into actionable improvements.
Excellent technical writing for validation protocols/reports, SOPs, and risk documents.
Effective stakeholder communication and presentation; capable of influencing cross-functional teams.
Project management: planning, prioritisation, and delivery against timelines.
Hands-on aptitude with equipment and process troubleshooting; ability to work on the shopfloor.
Proficiency with Microsoft Excel (advanced), Minitab/JMP (or equivalent), and CI toolsets.

Relevenat Experience:

3–5 years’ experience in a manufacturing environment with direct responsibility for process improvement and validation.
Demonstrated experience executing IQ/OQ/PQ, developing validation protocols/reports, and managing change control.
Track record of delivering measurable improvements in yield, scrap, OEE, cycle time, and right-first-time metrics.
Experience with PFMEA/Control Plans, SPC, DOE, and root cause analysis methods.
Exposure to new product/process introductions, equipment upgrades, and technology transfers.
Experience working within a regulated quality system (e.g., ISO 9001; ideally ISO 13485 or EU GMP/HPRA depending on industry).

Person specification & core competencies:

Team player with strong work ethic; collaborative, dependable, and solutions-oriented.
Takes responsibility for outcomes; follows through and escalates risks early.
Continuous Improvement Mindset. Curious, data-driven, and relentless about eliminating waste and variation.
High standards for documentation, validation rigor, and compliance.
Clear communicator who can engage operators to senior leaders; builds trust and alignment.
Organises work effectively and delivers to committed timelines.
Thrives in a dynamic, fast-paced environment; responds constructively to change.
Safety & Quality First: Champions EHS and quality culture; role-models best practice on the shopfloor.