Aseptic Operations Specialist

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, LinkedIn and Tik Tok.

At AbbVie, we are committed to delivering innovative medicines and solutions that make a remarkable impact on people’s lives. Our employees are driven by a shared purpose, a culture of integrity and inclusion, and a focus on excellence in science, manufacturing, and patient care.

At our Ballytivnan site in Sligo, we are seeking an experienced Aseptic Operations Specialist to join our team and support the continued delivery of safe, compliant, and high-quality aseptic manufacturing operations.

The Role

As an Aseptic Operations Specialist, you will act as a site subject matter expert for aseptic manufacturing and sterility assurance. You will provide technical and operational support across aseptic processes, partner closely with cross-functional teams, and help ensure that manufacturing activities are carried out in line with regulatory requirements, site procedures, and AbbVie standards.

This role plays a key part in maintaining a strong culture of quality, compliance, continuous improvement, and speak-up behavior across the site.

Key Responsibilities

• Act as a site subject matter expert for aseptic manufacturing.
• Provide key input into manufacturing process setup and batch record design.
• Ensure operations procedures for aseptic manufacturing are compliant with relevant safety, environmental, GMP, and regulatory requirements, as well as network aseptic best practice.
• Apply risk management tools to drive aseptic performance and sterility assurance, including pFMEA and What If/HAZOP assessments.
• Partner with Quality, Engineering, Aseptic MQA, Aseptic Mentors, and other site SMEs to support manufacturing shifts and ensure safe, timely, and quality completion of product batches.
• Observe aseptic technique and behaviors on the floor and provide coaching and feedback where appropriate, particularly during critical activities such as cleaning, sanitization, aseptic setup, EM plate handling, and interventions.
• Lead and support investigations into sterility, media fill, environmental monitoring excursions, and EMPQ issues, and help establish root cause and CAPA.
• Own the analysis and trending of environmental monitoring data, including facility and personnel monitoring, and develop action plans in response to trends.
• Contribute to the ongoing development and implementation of best practices in aseptic manufacturing.
• Support the site contamination control strategy, aseptic processing strategy, and long-range planning related to aseptic manufacturing.
• Provide input into cleanroom, equipment, and utility design, qualification and re-qualification, preventive maintenance strategies, and real-time monitoring.
• Support regulatory audits and inspections as an aseptic and sterility assurance subject matter expert.
• Support training of operations personnel in aseptic technique and aseptic processing procedures.
• Participate in routine leadership GEMBAs in manufacturing and testing areas.
• Perform other duties as assigned.

Qualifications and Experience

Essential

• Level 8 NFQ degree in Science, Quality, or Engineering.
• Minimum 5 years’ experience in a GMP environment.
• Minimum 3 years’ experience supporting aseptic manufacturing.
• Strong knowledge of regulatory requirements.
• Strong communication skills, both written and verbal.

Desirable

• Project management experience.
• Experience supporting regulatory inspections, including HPRA and FDA.
• Experience in microbiology.
• Experience working in a sterile, aseptic, or pharmaceutical environment.

Knowledge, Skills and Attributes

• Strong knowledge of aseptic and sterile processes.
• Working knowledge of current EU, FDA, ICH, HPRA, and Annex 1 requirements.
• High attention to detail and strong concentration.
• Proven problem-solving skills and ability to adapt to changing requirements.
• Innovative mindset with the ability to propose and implement new solutions.
• Results-driven with a commitment to meeting targets and metrics.
• Strong prioritization and time management skills.
• Excellent interpersonal and collaboration skills.
• A strong commitment to quality, integrity, and right-first-time performance.
• Ability to work independently in a largely self-managed environment while engaging effectively with the wider team.

What We Offer:

At AbbVie, you will be part of a team that is committed to excellence, collaboration, and continuous improvement. This is an opportunity to contribute to a site that values quality, compliance, and innovation, while making a meaningful impact through your expertise in aseptic manufacturing.

Apply today to start your journey with AbbVie!

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. 

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