LIMS Templator / LIMS Data Entry

Orion Group Life Sciences are currently recruiting a Senior Technical Writer for our Multinational Biopharmaceutical client located in Dublin for an initial 12-month contract.

The Laboratory Information Management System (LIMS) Upgrade project requires LIMS Templators / LIMS Data Entry resources to support the data migration, LIMS templating and data entry efforts under the guidance and direction of the Business Workstream Lead and Project/Program Management.

This job specification outlines the general responsibilities associated with the role of LIMS Templator / LIMS Data Entry

* Work within the LIMS Modernization Project Team to provide laboratory business administration, implementation and technical support services for SM-LIMS, Biovia Smartlab (LMES) and Biovia CIMS (Inventory Management).

* Review of Quality Documentation e.g. Sample Plans, FORMs and Environmental Monitoring sample plans, Methods, Specifications to:

o Build, develop and maintain LIMS templates.

o Evaluate new or revised LMES eProcedures in conjunction with SMEs.

o Provide support for LMES eProcedure revisions

o Provide support for CIMS updates

* Work with the Documentation Writers to:

o Provide support for SOP updates.

o Assist with developing and deliver training documents.

o Assist with UAT script writing

* Be responsible for specific tasks within several workstreams associated to the LIMS Modernization Upgrade project.

* Ensure timely completion of each stage of the Project Tasks

* Ensure flow of communication to stakeholders.

Key Competencies:

* Apply analytical thinking to evaluate and interpret complex situations/problems using multiple sources of information.

* Excellent verbal and written communication skills including technical writing, presentation and facilitation skills.

* Work collaboratively with global business team

* Ability to work under minimal supervision.

* Ability to work in a fast paced environment with changing priorities.

* Excellent Organizational and Time Management Skills.

* Ability to identify and manage competing priorities.

* Anticipate and prevent potential problems.

* Skills in the areas of teamwork, flexibility, coaching and motivating.

Knowledge and Experience:

* Hold a third level qualification in a Science related discipline.

* Minimum 4 years experience in a Biotechnology/ Pharmaceutical/ GMP Environment.

* Familiar with (or can learn) new laboratory information systems and can self-teach technical topics.

* Familiar with system validation of computerized systems.

* Familiar with SQL querying, excel logic, java or html is a plus.

* Knowledge of lab operations, analytical lab techniques, commercialization, and cGMP.

* Knowledge on Data Integrity Assessments (DIA) for computerized systems and execution of CFR 21 Part 11 for computerized systems.

* Experience as a user (as a minimum) of LIMS Syste

For more information on this role, call Beatriz Olmedo on +353 21 235 2900 or email beatriz.olmedo@orioneng.com for a completely confidential chat about this role and other opportunities.

Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.