Process Engineer

2 weeks ago

Limerick, Limerick, Ireland PM Group Full time
Overview

The Outsourced Technical Services (OTS) Department at PM Group partners with Global leaders across a range of industries to find the best people for their current and ongoing business needs. Partnering with PM Group and our clients means that you will gain unrivalled experience working with global brands.

We are seeking a skilled and motivated Process Engineer to join our team at a state-of-the-art biopharmaceutical manufacturing facility in Limerick. The successful candidate will provide technical support for production operations and lead or contribute to various engineering projects aimed at process improvement, efficiency, and compliance. This role is critical in ensuring that production processes operate smoothly, reliably, and within regulatory guidelines.

Responsibilities

- Provide day-to-day technical support to manufacturing operations, troubleshooting process issues to minimize downtime.
- Monitor and analyze process performance data to ensure manufacturing processes meet quality, efficiency, and safety standards.
- Identify and implement corrective and preventive actions (CAPAs) for production-related deviations.
- Support equipment qualification and validation activities, including generation and execution of protocols (IQ, OQ, PQ).
- Lead or support engineering projects, including process optimization, new technology implementation, and capacity expansion initiatives.
- Develop detailed project plans, timelines, and budgets.
- Coordinate with cross-functional teams (e.g., QA, QC, Manufacturing, Maintenance) to ensure successful project delivery.
- Evaluate and recommend process improvements to enhance throughput, efficiency, and cost-effectiveness.
- Ensure all activities comply with regulatory requirements (e.g., FDA, EMA, cGMP).
- Develop and maintain detailed process documentation, including batch records, standard operating procedures (SOPs), and engineering specifications.
- Participate in regulatory inspections and audits, providing technical expertise as needed.
- Utilize lean manufacturing, Six Sigma, or similar methodologies to drive continuous improvement efforts.
- Train operations staff on process changes and new technologies.
- Stay up-to-date with industry trends, innovations, and best practices in biopharmaceutical manufacturing.

Qualifications

- Bachelor's degree in Chemical Engineering, Biochemical Engineering, or a related discipline. A Master's degree is advantageous.
- 3+ years of experience in a process engineering role within the biopharmaceutical, pharmaceutical, or biotechnology industry.
- Hands-on experience with GMP manufacturing environments and regulatory requirements.
- Proven track record of supporting production operations and executing engineering projects.
- Strong understanding of upstream and/or downstream biopharmaceutical processes.
- Familiarity with process control systems (e.g., DeltaV, PLCs) and data analysis tools.
- Knowledge of lean manufacturing and Six Sigma principles.
- Proficiency in project management tools and methodologies.
- Strong problem-solving and analytical skills.
- Excellent communication and interpersonal skills, with the ability to work effectively in a cross-functional team.
- Self-motivated, detail-oriented, and able to prioritize multiple tasks.

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