Lead Operator/Operations Process Lead

R&D Partners; Munster; On-site; EUR 65,000 - 90,000; Full time

Job summary

R&D Partners in Ireland seeks a Manufacturing Team Lead to oversee daily operations in a pharmaceutical/medical device environment. You will ensure safety, quality, compliance, and delivery goals, acting as a technical expert for manufacturing processes and leading ongoing improvements.

You will train team members, maintain production records, and support regulatory inspections by HPRA and FDA, while promoting lean manufacturing and 5S to raise efficiency and product quality.

Qualifications

• Proven leadership experience in a manufacturing setting, preferably pharma/medical device.
• Strong understanding of manufacturing processes and quality systems.
• Knowledge of cGMP (current Good Manufacturing Practices) and cGDP (current Good Documentation Practices).
• Ability to train and guide team members effectively.
• Experience with continuous improvement methodologies such as lean manufacturing and 5S.

Responsibilities

• Oversee daily manufacturing activities to ensure safety, quality, and compliance.
• Ensure products meet quality standards and are stored properly.
• Approve and implement production instructions and maintain accurate documentation.
• Monitor and control the manufacturing environment for cleanliness and compliance.
• Support inspections by regulatory agencies (HPRA, FDA).
• Train team members on procedures to meet quality and operational standards.
• Identify and resolve safety, quality, equipment, or materials issues.
• Collaborate with support teams to introduce new products, equipment, and processes.
• Drive continuous improvement efforts, including lean manufacturing and 5S.

Skills

Leadership

Pharma manufacturing

cGMP

cGDP

Problem-solving

Lean

5S

Regulatory knowledge

Job description

Lead the line, elevate performance, and drive excellence in every step of the manufacturing process.

R&D Partners is seeking a dedicated and detail-oriented Manufacturing Team Lead to oversee daily manufacturing activities. In this role, you will ensure smooth, safe, and compliant operations while meeting delivery goals. You will act as a technical expert for manufacturing processes and collaborate with various teams to maintain high standards of quality and efficiency.

Please note that to be considered for this role you must have the right to work in this location.

Responsibilities:

• Ensure safety and environmental policies are followed during all activities.
• Oversee production to ensure products meet quality standards and are stored properly.
• Approve and implement production instructions and ensure compliance.
• Maintain accurate production records and ensure proper documentation.
• Monitor and control the manufacturing environment for cleanliness and compliance.
• Support inspections by regulatory agencies such as HPRA and FDA.
• Train team members on procedures to meet quality and operational standards.
• Identify and resolve issues related to safety, quality, equipment, or materials.
• Collaborate with support teams to introduce new products, equipment, and processes.
• Drive continuous improvement efforts, including lean manufacturing and 5S activities.
• Actively participate in manufacturing tasks, including documentation and process validation.
• Provide leadership and feedback to develop team members' technical skills.

Key Skills and Requirements:

• Proven working years of experience in an operator role, alongside experience in a leadership position within a pharmaceutical or medical device manufacturing plant.
• Strong understanding of manufacturing processes and quality systems.
• Knowledge of cGMP (current Good Manufacturing Practices) and cGDP (current Good Documentation Practices).
• Ability to train and guide team members effectively.
• Problem-solving skills to address operational challenges.
• Familiarity with regulatory requirements and inspection readiness.
• Commitment to maintaining a clean and safe work environment.
• Experience with continuous improvement methodologies like lean manufacturing.

For more information, please contact Billy O'Brien.