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AbbVie

AbbVie

Lab & IT Systems Engineer(Abbvie)

Posted :2 years ago
Job type
Full time
Job Descriptions

At AbbVie, our strength lies in our team of experts who conduct ground-breaking science on a global scale every day. In choosing your career & life path, choose to be extraordinary!

 

AbbVie’s operations in Carrigtwohill, Cork is a modern bulk tablet finish facility which manufactures solid and capsule formulations. Innovative new technologies, in combination with the depth of expertise that exists within the local workforce, has allowed those based there to develop and deliver products and processes to support AbbVie’s wider global needs. These range from small scale clinical trial supply to large commercial manufacturing.

 

The Lab & IT System Engineer primary duties will include but not be limited to providing hands on end user support, administration, installation, and issue resolution for GxP controlled laboratory and Business Technology Solution (BTS) systems, servers, desktops, and software packages.

 

Responsibilities:

•            Support and maintenance of all IT aspects of Laboratory and BTS systems.

•            Respond to and troubleshoot IT issues associated with instruments, servers, workstations, networks etc.

•            Collaborate with the business and vendors to resolve technical IT software and hardware problems as required.

•            Execute routine system administration and maintenance activities as required (Including system audit trail review, system patching, back-up and restore and system recertification)

•            Record all incidents, support issues and changes using the SNOW tool.

•            Perform and Support IT technical Qualification and Validation activities as led by the business in conjunction with the validation and quality teams.

•            Ensure that all IT aspects of BTS systems are kept in a compliant state, and that all maintenance and system enhancement activities are carried out in a compliant manner in accordance with Abbvie policies and procedures.

•            Support and manage the implementation of Business Technology Solution (BTS) projects

•            Create and maintain system documentation including procedures, work instructions system design specifications, user requirements, functional requirements, or routine controlled application change forms.

•            Develop/Modify/Update SOPs, Work Instructions and Business Process and data flows for each system, and its interfaces.

•            Acting as key point of contact for internal and external customers to lead BTS projects through to completion.

•            Identify, evaluate and implement opportunities for improvement in current BTS systems and processes.

•            Will need to cross-qualify and take backup responsibility within the team for manufacturing IT scope

•            Ensure Laboratory & BTS systems compliance with security and data integrity policies and regulatory requirements.

•            Adheres to and supports all EHS & E standards, procedures and policies.


Education and Experience:

•Bachelors or Master’s Degree in Engineering, Information Systems, Computer Science or comparable qualification through practical experience in the lab IT field

•At least 5 years’ experience providing hands-on IT systems support in the biotechnology or pharmaceutical industries.

•Experience of working with Windows Operating systems, Active Directory, Anti-Virus, TCP/IP, DNS, DHCP, networking protocols, and databases.

•Ability to work independently with minimum direct supervision.

•Experience of Pharmaceutical Industry Regulations cGMP/cGLP, 21 CFR 11 and EU Annex 11 compliance requirements.

•Experience working with all disciplines in and supporting a Laboratory environment including QA, CSV, QC, Lab Analysts.

•The position has a high level of autonomy and individuals are expected to work on their own initiative.

•Develops Lab IT System procedures to provide best value for the site

•Completes all changes and updates with product and employee safety in mind.

•Maintains systems in line with the latest guidelines on system and software integrity and validation.

•Demonstrates an ethos of Right First Time at all times.

•Adheres to and follows all procedures, policies and guidelines ensuring compliance with cGMP and HPRA/FDA regulations and company policies, procedures and guidelines.


AbbVie 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.


Travel: No

Job Type: Experienced

Schedule: Full-time


Qualifications

Bachelors Degree

Skills
Experience
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