Manufacturing Operations Technician - GMP & ERP

PBC Biomed; Shannon; On-site; EUR 32,000 - 42,000; Full time

Job summary

PBC Biomed is seeking an Operations Technician to support the production and supply chain teams in day-to-day manufacturing activities. You will work closely with cross-functional teams to ensure schedule adherence and compliance with GDP/cGMP standards in a regulated environment.

You will review batch records, support KPI tracking, and assist in change controls, validations, and continuous improvement initiatives.

Qualifications

• Experience in a regulated environment is required.
• Excellent communication, planning, interpersonal and presentation skills are essential.
• Hardworking and highly motivated with the ability to work independently and in a team.
• Strong technical acumen to understand complex concepts and develop practical solutions.
• Strong attention to detail to ensure accuracy in testing and documentation.
• Ability to adapt to a dynamic environment with changing priorities.
• Experience with GDP and current good manufacturing practices (cGMP).

Responsibilities

• Support the manufacturing of medical device, veterinary, and development products in line with SOPs and procedures.
• Coordinate daily production activities and assist in workload organization to meet schedules.
• Provide operational guidance to production team members per SOPs.
• Review batch records and production documentation.
• Help track KPIs related to production and supply chain performance.
• Support change controls and CAPA actions in collaboration with the team.
• Assist with validation activities including equipment protocols and calibrations.
• Contribute to process validation, risk management, and continuous improvement initiatives.
• Review project schedules, identify risks, and escalate issues.
• Communicate with key suppliers to support improvements in processes, equipment and materials.
• Support ERP system implementation and ongoing operation.
• Maintain a cleanroom environment per company procedures and regulatory standards.
• Carry out routine production activities and maintain training records.
• Ensure health, safety and environmental requirements are met.

Skills

Communication

Planning

Interpersonal skills

Presentation skills

Team player

Attention to detail

GDP knowledge

cGMP knowledge

Technical aptitude

Problem solving

Tools

ERP system

Job description

PBC Biomed is seeking an Operations Technician to support the production and supply chain teams in day-to-day manufacturing activities. You will work closely with cross-functional teams to ensure schedule adherence and compliance with GDP/cGMP standards in a regulated environment.

You will review batch records, support KPI tracking, and assist in change controls, validations, and continuous improvement initiatives.