Job Description

Company Description

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  . Follow @abbvie on  X ,  Facebook ,  Instagram ,  YouTube ,  LinkedIn and  Tik Tok .

Job Description

People. Passion. Possibilities. Three words that make a world of difference.

We currently seek for a Validation Engineer to join our Site Validation Team on a permanent basis, reporting directly to the Site Process and Cleaning Validation Lead in AbbVie Westport. As our new Sterilization Validation Engineer, you will be responsible for ensuring that medical devices, pharmaceutical products, and equipment are sterilized effectively and consistently to meet regulatory and quality standards. We perform all validation activities n line with Global Standards, FDA, HPRA and other MOH regulatory requirements.

Qualifications

So let’s tell you a little more about this role…

Key responsibilities:

• Design, execute, and document sterilization validation protocols for various sterilization methods (e.g., steam, ethylene oxide, gamma, electron beam).
• Develop and optimize sterilization processes in compliance with regulatory requirements (FDA, ISO 11135, ISO 13485, etc.).
• Analyze validation data, interpret results, and prepare detailed technical reports.
• Lead and support risk assessments related to sterilization processes, ensuring product safety and efficacy.
• Collaborate with manufacturing, quality assurance, and regulatory teams to address non-conformances and process improvements.
• Maintain and update documentation related to sterilization validation activities.
• Stay current with advancements in sterilization technology and industry best practices.
• Provide support for audit preparation, direct audit interaction and involvement in audit responses ·
• Support and comply with internal EHS requirements, procedures and policies. Ensure continued conformance to EHS within the department. Achieve the companies stated quality objectives through continuous improvement efforts and conformance to quality standards. Attend Departmental and APEX meetings and participation in any quality and safety initiatives.

Additional Information

Technical Skills and Experience required:

• Bachelor’s Level 8 Degree in Science, Engineering or related discipline.
• Minimum 4 years of experience in sterilization validation within medical device or pharmaceutical industry.
• Strong knowledge of regulatory standards and validation principles.
• Excellent analytical, problem-solving, and communication skills.
• Understanding of Process Validation, Computer system Validation, CPV, Sterilization, Packaging systems and related technologies.
• Good interpersonal and communication skills essential for working across multi-functional teams
• Comfortable to take on large / complex projects containing multiple modules and multiple Vendors with interlinked systems.
• Ability to respond to emergency changes that may present themselves while maintaining high levels of GxP throughout the validation effort.

So, does this all sound like the right role for you? Then come join 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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