Exciting opportunity available for an experienced Senior Specialist IS Business Systems Analyst to join our client’s biopharmaceutical manufacturing facility based in Dublin.
The successful candidate will provide support for existing Quality and Laboratory information systems and will lead the implementation of new Quality and Laboratory information systems.
 
Why you should apply:

• This is an excellent opportunity to join a world class manufacturing operation, with an outstanding track record of reliably delivering high-quality medicines to patients around the world suffering serious illnesses.
• There is a strong culture of continuous improvement and innovation within the company to strive for solutions that improve health outcomes and dramatically improve people’s lives.
• Our client is developing the capability to produce all its medicines in Dublin, helping to ensure continuity of supply of our medicines as they expand internationally.

 
What you will be doing:

• Develop support plans for systems including any required contracts with vendors or third parties, ensure all parties are aware of their responsibilities
• Ensures that systems are robust, reliable, and available to meet business demand
• Ensures that systems are maintained in a compliant manner according to the IS quality system
• Ensures systems have appropriate disaster recovery plans and processes including contingency plans
• Develop lifecycle plan for Quality and Laboratory Systems
• Proactively engage with Quality and Laboratory teams to encourage the use of technology to maximize efficiency, capacity and reliability or operations
• Develop innovative approaches to solve business challenges with current or new technology
• Plan and execute Quality & Laboratory information systems projects including the building configuration of PC’s for use in a GLP environment according to GAMP 5 and CFR 21
• Coach system users in the complaint and efficient use of their systems
• Aligns with relevant corporate business and IS teams to ensure that IS strategy for Quality and Laboratory systems is aligned with company goals and standards
• The individual will be capable of providing technical leadership to the site while ensuring that new initiatives are well defined, have a valid business case and are aligned with similar initiatives within the company.

• Education requirements are a Bachelors degree in Engineering, Information Systems, Computer Science or the Life Sciences.
• The successful candidate will have at least 5 years experience providing Quality and/or Laboratory information systems solutions and support to manufacturing organizations in the biotechnology or pharmaceutical industries.
• Candidates should demonstrate technical, project and interpersonal skills, including but not limited to the following: client interfacing and resolution of client concerns, project definition and business case development, proactive support and resolution of issues, technical guidance from concept to delivery, system delivery, commissioning and validation.
• Candidates must have demonstrated experience in the delivery and management of information systems in addition to a working knowledge of GAMP software development lifecycle, and appropriate development methodologies for information systems.
• Experience with Empower CDS, Gen 5, Tecan, Maldi Biotyper, Tiamo, LMES, Sample Manager LIMS, Laboratory Analytical Equipment and instruments and Trackwise will be an advantage.
• Day to day vendor management experience
• Knowledge of System Architecture including underlying infrastructure and the structure of software solutions
• Should have experience with Enterprise systems, validation, testing and change control