Senior Manufacturing Technician

AbbVie Inc.; Ballytivnan; On-site; EUR 55,000 - 75,000; Full time

Job summary

AbbVie Inc. in Ballytivnan, Sligo is seeking a Senior Biologics Technician to join the Biologics Operations Department.

The role requires contributing to GMP-compliant manufacturing activities, supporting change controls, investigations and CAPAs, and ensuring smooth shift operations. The successful candidate will have a 3rd level science qualification and 3+ years of biologics experience, with a commitment to safety and regulatory compliance.

Qualifications

• 3rd level qualification in a relevant science discipline.
• 3+ years experience in a biologics position.

Responsibilities

• Support biologics operations in line with GMP and safety.
• Assist with change controls, investigations and CAPAs for the Biologics Operations Department.
• Coordinate between shift teams to ensure excellence in GMP/safety and manufacturing activities.

Skills

Biologics experience

Education

3rd level qualification in a relevant Science discipline

Job description

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,XandYouTube.

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 – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X,Facebook,Instagram,YouTube,LinkedInandTik Tok.

Science is at the heart of what we do. People are at the heart of why we do it.

Welcome to AbbVie!

We are a global, research-based biopharmaceutical company that combines the focus and passion of leading-edge biotech with the expertise and capability of an established pharmaceutical leader. Redefining what is possible is our business and our passion. Our goal is to help patients live healthier lives and we are proud to be a Great Place to Work.

We are recruiting aSenior Biologics Technicianto join our site inBallytivnan, Sligo.This role will require shift work.

Are you intrigued? Do you want to learn more?

A snapshot of your key responsibilities as a Senior Biologics Technician would be:

• To work as a team member to support biologics operations in line with all safety, regulatory and organizational requirements.
• Provide support on change controls, investigations, tasks and CAPAs for the Biologics Operations Department.
• To support the Operations Lead in line with safety, regulatory and organisational requirements when delegated responsibility.
• Co-ordination between shift teams to ensure excellence in GMP/ safety and manufacturing activities
• Point of Contact for Manufacturing issues which arise and if escalation to Supervisor is required.
• Efficiently operate all biologics processes minimizing material loss.
• Operate Fill Line, Autoclave, Equipment Washer, Headspace Analyzer, Filtration Systems, Equipment Cleaning and Sterilization, Equipment Pressure Tests, Equipment/Filters Integrity Tests, Water Baths, Isolators and Lyophiliser, as applicable.
• Perform Operations Batch Review as Required
• Perform final product visual inspection, as required
• Perform product intermediary packaging, as applicable.
• Assemble and inspect equipment in the manufacturing area to confirm its operational status.
• Perform all in process testing methods.
• Material receipt from warehouse, verifying all pertinent documentation & completion of all relevant transactions on SAP/POMS
• Completion of Inventory Counts, as required
• Transfer of final material to warehouse inventory.
• Perform process tests and participate in qualification and validation activities as required.
• Ensure all manufacturing documentation is completed on a timely manner without errors, following cGMP’s
• Diagnose and resolve events or exceptions of production equipment and processes.
• Disposal of domestic, biomedical, and hazardous waste from their respective area as applicable, ensuring compliance with regulations following the procedures and policies of the plant, division, and the corporation.
• Keep detailed records, manual or electronic, of the operations carried out during the work shift.
• Active Participation in Factory Acceptance testing, Site Acceptance Testing and commissioning and qualification of equipment.
• Adhering to all relevant policies relating to Quality & Safety.
• Ensure successful external inspections, and Division and Corporate audits.
• Active participant in the development of batch records and electronic batch records for the site & primary reviewer for the batch records in development.

Qualifications

What you will need:

• 3rd level qualification in a relevant Science discipline
• 3+ years experience in a Biologics position

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.

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html