Pharmaceutical Technology Specialist III (Computer Systems Validation Engineer)

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. 

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 Validation Engineer is responsible for the qualification and validation of equipment, systems, and processes as per site validation master plan. A list of key duties and responsibilities are listed in more detail in the subsequent sections. All Validation activity is to be performed in line with Global Standards, FDA, HPRA and other MOH regulatory requirements.

Responsibilities:

• Over-see, Coordinate, guide and implement the site validation master plan under prospective, concurrent, and retrospective validation studies in a timely manner, with the relevant engineers to ensure that all validation requirements are met for any new process, equipment or change to existing processes or equipment.
• To actively work on validation projects, being the departmental point person and completing all associated project documentation in line with current corporate and regulatory expectations. To ensure that all documentation pertaining to each validation study under his/her responsibility is compiled, authorized, and filed in a timely and organized fashion.
• To work with the other validation engineers to achieve compliance by coordinating each validation project assigned. The process involves the review and approval of validation documentation and co-ordination of the validation work.
• Keep abreast of current and changing regulatory guidance’s for the relevant areas of validation that applies.
• Provide support for audit preparation, direct audit interaction and involvement in audit response
• Knowledge to monitor and review computerised systems (CS), ensuring that the CS remain in a validated state. This includes compliance to regulatory requirements, compliance to corporate and site standards and procedures.
• 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.

• Bachelor’s Level 8 Degree in Science, Engineering or related discipline.
• Thorough understanding and application of GMP and regulatory requirements
• Minimum 2 years’experience in the Validation industry.
• A Good understanding of computer system validation and qualification, SCADA systems.
• Good Knowledge of GAMP 5 categorisation of computerised systems.
• Design and build validation plans for computerised systems from the concept phase of a project through to the end of life of a system.
• A strong understanding of current data integrity expectations would be a distinct advantage.
• Contribute within an agile team to support Commissioning, Qualification and Validation activities in close collaboration with cross functional departments such as Engineering, Manufacturing, Quality, Automation, Project Management.
• A proven track record that demonstrates the ability to work without direct supervision whilst maintaining adherence to project delivery is fundamental to the role
• Record and inform on outcomes of Commissioning, Qualification and Validation activities.
• 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, are you ready to be part of this ambitious and diverse team? Apply today! 

It’s important to remember, AbbVie is an Equal Employment Opportunity Employer; we value bringing together individuals from diverse backgrounds to develop innovative solutions for patients and being part of an inclusive work environment.

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.

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