Aseptic Operations Specialist

At AbbVie we are committed to delivering innovative medicines and solutions that make a remarkable impact on peoples 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 :

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.

Additional Information :

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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Work :

No

Employment Type :

Full-time