Operations Technician

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

As an Operations Technician you will assist and support the production and supply chain team with day-to-day activities related to product manufacture. The Operations Technician will play a critical role in the success of our product manufacturing initiatives and improvement of our products. Your ability to work collaboratively with cross-functional teams, attention to detail and technical expertise will contribute to the success of our product initiatives.

Role and Responsibilities

• Support the manufacturing of medical device, veterinary, and development products in accordance with company processes and procedures.
• Coordinate daily production activities and assist in organizing workload across the production team to ensure schedule adherence.
• Provide operational guidance to production team members in line with established SOPs and procedures.
• Review batch records and production documentation.
• Support tracking and reporting of KPIs relating to production and supply chain performance.
• Initiate and track change controls as required and support progression through internal systems.
• Support NCR, NCM, and CAPA actions in collaboration with the Production & Supply Chain Team Lead.
• Support validation activities including execution of equipment protocols, calibrations, and process validations.
• Assist in process validation, risk management, and continuous improvement initiatives.
• Support progress across projects by reviewing schedules, identifying risks, and escalating issues where necessary.
• Communicate with key suppliers to support process, equipment, and raw material improvements/developments.
• Support the implementation and ongoing operation of the ERP system.
• Ensure the manufacturing and warehousing area is maintained in accordance with company procedures and regulatory standards.
• Carry out routine production activities in a regulated cleanroom environment under established SOPs.
• Maintain training records and ensure all required training is up to date.
• Perform all duties in compliance with company policies and procedures.
• Ensure all health, safety and environmental requirements are met.
• Perform other related duties as assigned by the Production & Supply Chain Team Lead.

Quantifications and Education Requirements

• Relevant industry experience in a regulated environment.
• Excellent communication, planning, interpersonal and presentation skills.
• Hardworking and highly motivated with the ability to work both independently and as part of a team.
• Strong technical acumen and ability to understand complex technical concepts/issues and develop practical solutions.
• Strong attention to detail and ability to work meticulously to ensure accuracy in testing and documentation.
• Ability to work in a dynamic environment with changing priorities.
• Experience with good documentation practices (GDP) and current good manufacturing practices (cGMP).