Process Engineer

Process Engineer

On behalf of our Clinical Stage Gene Therapy Client based in Shannon, we are currently sourcing a Process Engineer to join their team.

Major Activities

• Manufacturing Support: Integration into the relevant business unit that supports manufacturing requirements in a highly regulated GMP environment for the manufacture of Advanced Therapeutic Medicinal Products (ATMPs).
• Capital Projects: Support the design and review of capital projects, particularly for single-use biopharmaceutical manufacturing equipment.
• Vendor Coordination: Coordinate vendor activities for commissioning, qualification, maintenance, calibration, and process improvements.
• Technical Transfer: Support technical transfer activities, including design and developing specifications for single-use equipment items. Provide SME input to Process Failure Modes and Effects Analysis (FMEA).
• Engineering Standards: Assist in implementing and developing applicable engineering specifications and standards as they relate to local and multi-site Operations.
• Safety, Health, and Environment (SH&E): Provide SME input on SH&E programs, including risk assessments, safety investigations, and other safety improvement activities.
• GMP and Documentation Compliance: Ensure all work complies with GMP, Data Integrity, and Good Documentation Practice (GDP).
• Complete tasks according to applicable procedures and ensure timely and compliant training.
• Ensure timely and right-first-time (RFT) closure of GMP documentation, including issues, CAPAs, Change Controls, Batch Manufacturing Records (BMRs), and audit/inspection actions.
• Continuous Improvement: Demonstrate a right-first-time ethos while ensuring compliance with statutory, regulatory, and company standards, procedures, and systems.
• Waste Reduction and Energy Efficiency: Identify and implement technology-based and work practice solutions to reduce waste and overall cost.

Key Performance Indicators

• Deliver sustainable improvements measured by KPIs aligned with safety and quality compliance policies.
• Support project deliverables, ensuring on-time completion and adherence to quality standards.
• Proactively contribute to the development and effectiveness of the engineering team.
• Demonstrate experience working in a highly regulated cleanroom environment within the bioprocessing sector.

Key Job Competencies

• Comprehensive practical and theoretical background in a wide range of biopharmaceutical equipment and manufacturing processes.
• Familiarity with computerized equipment systems and data integrity principles.
• Experience with commissioning and qualification of process equipment and utilities.
• Strong problem-solving skills and the ability to resolve issues in a structured and timely manner.
• Leadership qualities with the ability to inspire and motivate others.
• High motivation with the ability to set and achieve challenging goals.
• Excellent planning and organizing skills with efficient time management.
• Professional demeanor with the ability to handle pressure and treat others with respect.
• Innovative thinking and creativity to meet challenges resourcefully.
• Effective communication skills, both verbal and written, with good presentation abilities.
• Job Responsibilities
• Compliance: Ensure conformance to Site Safety & Quality Management Systems requirements
• Projects delivery: According to approved scope, schedule and cost provisions.
• Manufacturing Support: Performance within the business unit to achieve SQSCT Goals & Targets.

Job Background

• Qualified to Degree Level in a related Engineering or Science discipline.
• Minimum 5 years’ experience in a biopharmaceutical environment in a process engineering role.
• Essential cleanroom working knowledge.
• Essential knowledge of biopharmaceutical process operations, including media and buffer preparation, upstream and downstream processing (e.g., single-use bioreactors, centrifuges, UF/DF, TFF).

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