Manufacturing Technician (Documentation Support)

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

• Full-time
• Workday Global Grade: 12

Company Description

About AbbVie

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on LinkedIn, Facebook , Instagram , X and YouTube.

Job Description

Welcome to AbbVie!

Our employees work every day to discover and address many of the world's most pressing health challenges. When you have patients depending on your solutions, you look for the best people to join the team.

We are excited to invite experienced and driven candidates to apply to ourManufacturing Technician (Documentation Support)opportunity here at AbbVie Westport. In your new role asManufacturing Technician (Documentation Support) you will ensure the continued success of our Biologics 2 business unit by taking ownership of various duties relating to CAPA and continuous improvement, documenting batch related activities, housekeeping and aseptic manufacturing. You will also have the opportunity to work with the latest industry tech and develop your skillset by joining a talented and high performing group.

Key Responsibilities

• Carry out daily tasks as assigned by the Senior Operations Manager according to GMP and the quality system.
• Active involvement and management of batch related CAPA’s as they arise in the business unit taking them from the initial review state through RCA, approval, batch disposition and delivery of corrective and preventive actions, liaising closely with the relevant Departments to ensure thorough investigation is completed and timely resolution and closure is met.
• Assist in the management and closure of existing CAPA’s through the evaluation of the current status of corrective and preventive action including interdepartmental co-ordination to ensure robust actions are in place to prevent reoccurrence prior to closure.
• Lead and support continuous improvement initiatives as required to support the overall goals of the Biologics 2 Process Team.
• Based on knowledge and previous experience you will also be requested to facilitate, support and generate RCA reports.
• Participate in GEMBA’s and Process Confirmations in an effort to identify further improvement opportunities within the department.
• Manage requirements in order to deliver the KPIs as they relate to the Product Flow function with specific emphasis on the batch release cycle.
• Carry out daily tasks as assigned by the Manager according to GMP and the quality system.
• Participating in root cause analysis and problem-solving.
• Completing compliant investigations and environmental excursions.
• Adhering to all company standards in safety, housekeeping and quality, notifying management of any discrepancies.
• Follow gowning procedures on entry to areas.
• Adhere to and support all EH&S standards, procedures, and policies.

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.

Additional Information

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.