Pharmaceutical Technology Specialist III

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 www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. 

Job Description

Join our dynamic Validation Department at AbbVie Westport and make a significant impact on the pharmaceutical industry. As a Pharmaceutical Technology Specialist III, you’ll play a vital role in ensuring the quality and compliance of our manufacturing processes. Your expertise will be instrumental in validating and revalidating critical equipment, systems, and processes to meet stringent regulatory standards.

Are you passionate about delivering high-quality products? If so, this is the perfect opportunity to contribute to our mission of providing exceptional healthcare solutions.

The Validation Department is responsible for the qualification / validation of all CGMP equipment, systems and processes utilized for routine operation at the AbbVie Westport manufacturing site. The Department is also responsible for the revalidation of critical systems & processes. 

The role of the Pharmaceutical Technology Specialist III is to ensure customer satisfaction is delivered with each, revalidation, validation and project work. All Validation activity is to be performed in line with Global Standards, FDA, HPRA and other MOH regulatory requirements. 

Duties will include:

Validation Master Plan:

• Oversee, coordinate, guide, and implement the site validation master plan.
• Ensure timely completion of prospective, concurrent, and retrospective validation studies.
• Collaborate with relevant engineers to meet all validation requirements for new processes, equipment, or changes to existing systems.

Project Management:

• Actively work on validation projects as the departmental point person.
• Complete all associated project documentation in compliance with corporate and regulatory standards.
• Ensure timely compilation, authorization, and filing of validation documentation.
• Coordinate with other validation engineers to achieve project compliance through effective collaboration and documentation review.

Review Processes:

• Facilitate the PQR review process, Regulatory Review Process, and Laboratory Equipment Review Process as per the current rotas.

Regulatory Compliance:

• Stay updated on current and evolving regulatory guidance for relevant validation areas.
• Provide support for audit preparation, direct audit interaction, and audit response.

EHS and Quality:

• Support and comply with internal EHS requirements, procedures, and policies.
• Ensure ongoing EHS conformance within the department.
• Contribute to achieving the company’s quality objectives through continuous improvement efforts and adherence to quality standards.
• Actively participate in Departmental and APEX meetings, as well as Quality and Safety Initiatives.

Qualifications

• Bachelor’s degree required in science based or engineering discipline
• Experience in a similar role in the Pharmaceutical industry
• Excellent project management skills
• Proficient in use of Microsoft Office suite of programs
• Critical Thinking and Problem Solving skills

Additional Information

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.

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

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