Process Engineer

Role Purpose:

• Our client, a state-of-the-art drug substance and drug product manufacturing facility based in Co. Louth, is seeking a Process Engineer to support their team on site.
• Responsible for delivering process engineering support within a regulated manufacturing environment, ensuring processes are robust, compliant, and aligned with operational objectives.
• Leads and supports process validation, equipment qualification, technical investigations, and continuous improvement initiatives to maintain high standards of safety, quality, and performance.

Core Duties and Responsibilities:

• Coordinate, execute and document qualification activities, process studies and product programs as required.
• Generate, review and approve process documentation.
• Execute development and qualification studies across commercial and non-commercial products.
• Develop and qualify new processes.
• Qualify new equipment where appropriate.
• Provide technical support for commercial manufacturing operations.
• Provide technical support for new product introduction activities.
• Lead and support investigations and troubleshooting of process-related issues.
• Represent the Technical Operations/Engineering function at cross-functional meetings.
• Ensure compliance with Quality Management System (QMS), cGMP and regulatory requirements.
• Complete documentation, risk assessments and corrective actions in a timely manner.
• Support audit readiness, including preparation of supporting documentation and participation in audits and inspections.
• Ensure adequate processes and procedures are in place and adhered to for all relevant process activities.
• Participate in and support continuous improvement initiatives and structured problem-solving activities.
• Apply technical knowledge to author technical documents and support sound technical decision-making.
• Support business-critical projects related to process and technical operations.
• Contribute to a safe, compliant and high-performing working culture.
• Manage and support change control activities and compliance commitments (senior level).
• Lead process initiatives and introductions as required (senior level).
• Perform other duties as assigned.

Education & Qualifications Required:

• Bachelor’s degree or higher in Science, Engineering or a related technical discipline (preferred).
• Experience in a regulated manufacturing environment.
• Strong knowledge of cGMP and regulatory requirements.
• Experience in process validation, equipment qualification and technical documentation.
• Ability to lead or support investigations and apply structured problem-solving methodologies.
• Experience supporting audits and regulatory inspections.
• Strong technical writing and documentation skills.
• Effective communication and interpersonal skills with the ability to work cross-functionally.