Business Analyst (Labs)

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This role is responsible for the specification and design of IT solutions that directly support laboratory operations within OUR CLIENT 's new Biologic s Drug Substance Facility in Dublin.

The role is responsible for the successful implementation of IT solutions that directly support laboratory operations. This includes conducting developing and completing appropriate validation and testing, up to and including PQ. In addition, the role will have responsibility for ensuring that these systems are maintained in a validated state, and for keeping the underlying technology current, as part of an active lifecycle management program.

This role is responsible for the providing ongoing support to the IT systems that directly support laboratory operations. This role will be accountable for implementing system changes and conducting system investigations for specified Laboratory systems in such as manner as to ensure they maintain the safe and compliant operation of the site. In addition, this role will be responsible for implementing and maintaining the necessary local configuration of key laboratory systems (LIMS, CDS etc.) to ensure they accurately reflect the test methods and instrument setup within the facilities labs.

This role will require active and engaged participation in the site tier processes (routine operations support processes) as well as supporting a culture of continuous improvement at the site.

Qualifications, Skills & Experience

* 3+ years GxP (life science, pharma, med device) experience

* Decision making and problem-solving skills

* Experience with Manufacturing IT system implementation and validation (as per the SDLC methodology)

* Experience with the implementation and on-going support of Manufacturing IT solutions, particularly MES

Preferred Qualifications / Experience

* Experience with Bio-Pharmaceutical Drug Substance production

* Experience with facility commissioning and startup

* Demonstrated expertise with the following specific technologies

* CDS (Empower), LIMS (Labware)

* IT Integration Services

* Network and Server infrastructure