Process Engineer

Process Engineer

Hovione

Cork, Ireland

Purpose of the Role

Enable the efficient manufacture of pharmaceutical products, including highly potent compounds, while ensuring full compliance with cGMP and HSE requirements. The role is responsible for defining, implementing, improving, and supporting manufacturing processes and systems to deliver products safely, on time, within budget, and according to customer and business requirements.

Manufacturing Process Management

• Design, implement, optimize, and troubleshoot manufacturing processes.
• Ensure reliable, right-first-time production of intermediates and finished products.
• Support technology transfers, scale-up activities, and process improvement initiatives.
• Lead multiple process engineering projects and liaise directly with customers when required.
• Contribute to the design of new facilities and modification of existing installations.

GMP & Compliance

• Ensure compliance with all applicable cGMP, HSE regulations, internal procedures, and industry standards.
• Prepare and review GMP documentation including:
• • Batch Production Records (BPRs)
  • Campaign Reports
  • Change Controls
  • Validation Plans and Reports
  • Mass Balance Sheets
  • Bills of Materials (BOMs)
  • Operating Procedures and Manuals
  • Cost Proposals
• Participate in audits and inspections.

Risk Management & Investigations

• Conduct risk assessments for assigned activities and projects.
• Identify and document deviations, discrepancies, non-conformances, and abnormal events.
• Lead investigations and implement appropriate CAPAs.
• Proactively identify risks and opportunities for improvement.

Operational Support

• Monitor manufacturing performance and support production activities.
• Report equipment abnormalities and contribute to preventive and corrective maintenance activities.
• Support internal stakeholders with cost estimates, cycle times, and project-related information.
• Monitor and communicate trends impacting operational KPIs.

Continuous Improvement

• Drive productivity improvements through process optimization and introduction of new technologies.
• Evaluate and implement best practices, methodologies, and innovative solutions.
• Prepare project plans and business cases for optimization initiatives.

Training & Knowledge Sharing

• Train operators and technical teams on manufacturing processes, systems, and procedures.
• Support onboarding and qualification of new employees.
• Promote technical knowledge sharing and engineering excellence across teams.

Health, Safety & Environment

• Promote a strong safety culture and ensure compliance with all HSE requirements.
• Maintain high standards of housekeeping, hygiene, and equipment care.
• Carry out all activities safely and in accordance with company procedures and regulations.

Key Competencies

• Process Engineering
• Pharmaceutical Manufacturing
• cGMP Compliance
• Risk Assessment
• Technical Documentation
• Process Validation
• Technology Transfer
• Continuous Improvement
• Project Management
• Root Cause Analysis & CAPA
• Stakeholder Management
• Training & Coaching
• HSE Awareness
• Customer Focus

Success Measures

• On-time and right-first-time production delivery.
• Compliance with GMP and HSE requirements.
• Successful implementation of process improvements and tech transfers.
• Reduction of deviations and manufacturing inefficiencies.
• Achievement of operational and project KPIs.
• Effective support of customer and business requirements.

We are looking to recruit a Candidate:

• Degree in Science or Engineering, preferably Chemical Engineering.
• Mandatory experience in the pharmaceutical industry, particularly in:
  • Pharmaceutical Fine Chemistry
  • Particle Engineering
  • Drug Product Development and Manufacturing
  • Process Development and Scale-up
• Experience providing technical manufacturing support.
• Experience in equipment and technology design.
• Experience supporting technology transfer and capital projects.
• Experience managing multiple projects and products from development through commercial manufacture.
• Knowledge of GMP and HSE requirements (preferred).
• Intermediate knowledge of:
  • Organic Chemistry and/or Particle Engineering Technologies
  • Scale-up of Chemical Engineering Operations and/or Drug Product Manufacturing
• Strong project management and process improvement capabilities.
• Experience in troubleshooting, optimization, and continuous improvement initiatives.
• Strong stakeholder management and communication skills.
• Good written and spoken English.
• Proficient in Microsoft Office and SAP.
• Strong problem-solving, analytical, and root-cause investigation skills.
• Ability to work effectively in cross-functional teams and customer-facing environments.
• Committed to compliance, quality, safety, and operational excellence.