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Job Description
Process Project Engineer role at a leading Biopharmaceutical company in Co. Clare, responsible for supporting manufacturing requirements in a highly regulated GMP environment.
Our client is a leading Biopharmaceutical company in Co. Clare, committed to delivering innovative and quality products that save and improve lives around the world.
This role offers a competitive salary and full extensive company benefits package, with a dynamic environment for professional growth and development.
As a Process Project Engineer, you will be responsible for:
- Manufacturing Support: Integration into the relevant business unit that supports manufacturing requirements in a highly regulated GMP environment.
- 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).
- Continuous Improvement: Demonstrate a right-first-time ethos while ensuring compliance with statutory, regulatory, and company standards, procedures, and systems.
Key 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.
Requirements:
- Qualified to Degree Level in a related Engineering or Science discipline.
- Minimum 4-5 years experience in a biopharmaceutical environment in a process engineering or similar role.
- Cleanroom working knowledge.
- Knowledge of biopharmaceutical process operations, including media and buffer preparation, upstream and downstream processing.
- Proficient in English (verbal and written).