Biologics Manufacturing Technician - Documentation & CAPA

SmartRecruiters, Inc.; Waterford; On-site; EUR 32,000 - 42,000; Full time

Job summary

AbbVie Westport is seeking a Manufacturing Technician (Documentation Support) to contribute to the Biologics 2 Process Unit. You will own CAPA-related tasks, document batch activities, and support aseptic manufacturing, ensuring compliance with GMP and quality systems.

You will work with cross-functional teams, participate in root cause analysis, and help deliver KPI targets for the product flow and batch release.

Qualifications

• Leaving cert or equivalent qualification required.
• Third Level qualification in science or engineering discipline is an advantage but not essential.
• Understanding of the requirements to work in a regulated GMP industry.
• Ability to build strong relationships and work within cross-functional teams.
• Adaptability to work in a fast, dynamic environment whilst adjusting readily to meet unexpected constraints.
• Drive, high energy, maturity, and ability to work under pressure, deliver results, and overcome obstacles.
• Team player who can collaborate with others to achieve organizational targets and goals.
• Knowledge of biologics operations an advantage.

Responsibilities

• Carry out daily tasks according to GMP and the quality system.
• Active involvement and management of batch related CAPA’s from review through RCA, approval, batch disposition and closure.
• Assist in the management and closure of existing CAPA’s with interdepartmental coordination.
• Lead and support continuous improvement initiatives for Biologics 2 Process Team.
• Facilitate, support and generate RCA reports.
• Participate in GEMBA’s and Process Confirmations to identify improvement opportunities.
• Deliver KPIs as they relate to Product Flow with emphasis on the batch release cycle.
• Carry out daily tasks as assigned by the Manager according to GMP and the quality system.
• Participate in root cause analysis and problem-solving.
• Complete compliant investigations and environmental excursions.
• Adhere to safety, housekeeping and quality standards; notify management of discrepancies.
• Follow gowning procedures on entry to areas.
• Adhere to EH&S standards, procedures, and policies.

Skills

GMP knowledge

CAPA management

Documentation practices

Cross-functional teamwork

Regulatory compliance

Education

Leaving cert or equivalent

Science/Engineering degree (advantage)

Job description

AbbVie Westport is seeking a Manufacturing Technician (Documentation Support) to contribute to the Biologics 2 Process Unit. You will own CAPA-related tasks, document batch activities, and support aseptic manufacturing, ensuring compliance with GMP and quality systems.

You will work with cross-functional teams, participate in root cause analysis, and help deliver KPI targets for the product flow and batch release.