Process Engineer

Location: Carlow, Ireland

Join a Global Leader in Pharmaceutical Innovation
As a Process Engineer, you'll be at the heart of cutting-edge manufacturing processes in a dynamic, fast-paced environment. Working with a world-class team, you will support the development and execution of critical manufacturing operations, ensuring the highest standards of compliance, safety, and reliability. This is your chance to make a real impact within the pharmaceutical industry while advancing your career with a leader in the field.

Job Purpose
The Process Engineer will be responsible for driving the generation, review, and approval of essential GMP documentation, including Quality Notifications, CAPA records, SOPs, Standard Work Instructions, and change controls. The role ensures that all activities are aligned with company requirements to maintain compliance, safety, and a reliable supply chain for customers.

Principal Accountabilities

• Support Manufacturing: Collaborate closely with manufacturing teams by generating and expediting process investigations for non-GMP activities. Act as the go-to technical expert for MES (Manufacturing Execution System) functionalities, ensuring seamless integration and support for production.

• Documentation Management: Serve as a documentation expert, overseeing the creation, review, and approval of SOPs, SWIs, and training materials. Lead document system workflow expeditions, ensuring efficient management of change controls and batch release documents.

• Process Improvement: Investigate and resolve system issues using methodologies like FMEA, Fishbone diagrams, and the 5 Why’s. Lead the implementation of corrective and preventive actions (CAPA), ensuring continuous improvement in manufacturing processes.

• Compliance and Quality: Uphold the highest standards of cGMP compliance, adhering to Merck’s global policies and industry regulations. Ensure all production activities and documentation align with local and international codes and standards.

• Collaboration and Training: Work cross-functionally with various departments to foster a culture of safety and compliance. Assist with the management and delivery of IPT training to enhance team capabilities.

• Customer-Focused Solutions: Address customer complaints and manage change controls swiftly to support ongoing production and maintain client satisfaction.

Skills and Knowledge

Minimum Education:

• A Bachelor's degree (or higher) in Science, Engineering, or a related Technical discipline is preferred.

Experience:

• Demonstrated expertise within a manufacturing environment, ideally within GMP settings.
• Strong SAP knowledge, Microsoft Office proficiency, and experience with job-related software systems.

Core Competencies

Technical Expertise:

• SAP knowledge and hands-on experience.
• Understanding of international regulatory requirements and industry codes.
• Competency in process validation, equipment management, and sterile filling processes.
• Experience with Lean Six Sigma methodology is highly desirable.

Business Skills:

• Excellent communication and interpersonal skills, with the ability to work effectively across all levels of the organisation.
• Proven ability to coach, develop, and lead teams, fostering a collaborative and goal-oriented work environment.
• Strong analytical, problem-solving, and risk management skills.
• Effective time management and organisational capabilities, with attention to detail and multi-tasking abilities.

Leadership:

• Demonstrates a customer and patient-focused approach.
• Acts with integrity, courage, and transparency.
• Takes decisive actions to drive results and build talent within the team.

Reports To:
Operations Coach (Manufacturing Support)

For further information on this role, please contact Diarmuid Lannon on +353 861287246 or email consulting@hero.ie Check out all our open jobs on our HERO Recruitment website – https://www.hero.ie/

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