Laboratory Systems Lead
TR/077801
Posted: 28/05/2025
- Competitive Salary
- Ireland, County Meath, Dunboyne
- Contract
Orion Group Life Sciences are currently recruiting a Laboratory Systems Lead on behalf of our Multinational Biopharmaceutical Client based in Co. Meath on an initial 11-Month contract with potential to extend.
Job Purpose
This role will be part of the Technical Operations Team which is part of the Biologics AR&D in our single use multi-product Biologics facility.
The Laboratory Systems Lead will work across the site and AR&D to drive proactive programmes to allow the site to deliver the pipeline. The Laboratory Systems Lead will be responsible for supporting the implementation and configuration of Laboratory Systems. This role will support the laboratory teams for testing of incoming raw materials, in-process, drug substance/drug product, stability samples. This role will build the Lab IT Systems to support Tech Transfer/Commercialisation of the biologics pipeline.
Key Responsibilities
Educational and Experience Requirements
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.
Job Purpose
This role will be part of the Technical Operations Team which is part of the Biologics AR&D in our single use multi-product Biologics facility.
The Laboratory Systems Lead will work across the site and AR&D to drive proactive programmes to allow the site to deliver the pipeline. The Laboratory Systems Lead will be responsible for supporting the implementation and configuration of Laboratory Systems. This role will support the laboratory teams for testing of incoming raw materials, in-process, drug substance/drug product, stability samples. This role will build the Lab IT Systems to support Tech Transfer/Commercialisation of the biologics pipeline.
Key Responsibilities
- SME on data management systems for instrument control in the laboratories, this includes but is not limited to LIMS, Waters Empower, LabX, Softmax Pro, and other laboratory instrument controlling software.
- Build the Lab IT Systems to support Tech Transfer/Commercialisation and manufacturing of Biologics. Monitor and support the performance of the site Laboratory Systems according to cGMP and Systems Development Life Cycle (SDLC) standards such as change control and document management.
- Responsible for implementing industry best practices specific to Laboratory Systems processes that support sample management, testing and validation.
- Ensure site Laboratory Systems comply with changing requirements and trends in worldwide GMPs.
- Deliver training to relevant personnel on the correct application of the site Laboratory System procedures.
- Pro-actively participate in processes to ensure that the Laboratory Systems continue to function effectively and that improvement/remediation actions are taken such as Change Controls, Documentation Management, CAPAs and Audit Readiness.
- Continuous improvement of the Laboratory Systems - Identifying and building in efficiencies as necessary from a systematic and compliance perspective.
- Provide SME support for general troubleshooting, problem solving, technical direction and guidance to support overall business needs.
- Creates an environment of ‘right first time’ in everything that we do through a focus on principles of lean, including simplification, standard work, visual management and a learning organisation.
- Responsible for timely updates of site achievements and challenges. A collaborative approach, working cross functionally on resolving obstacles to maintain a highly effective and productive functional group.
Educational and Experience Requirements
- Degree qualification in a Technical discipline e.g. (Biochemistry /Chemistry /Engineering).
- At least 2 years’ experience in Laboratory Systems.
- Previous experience with configuring, building, maintaining laboratory management systems such as LIMS, LabX, Empower systems and an interest in coding/ script.
- Experience working in a GMP Regulated Pharma/Biopharma company or related industry is desirable.
- Have an understanding in analytical methodology (e.g., HPLC, ELISA, Glyco analytic, Bioassays, PCR, capillary electrophoresis, compendial assays).
- Have a working understanding of GMP, ICH, USP and global compendia regulations and guidance's, particularly as related to analytical method development and validation
- Excellent communication skills (written and oral).
- Strong technical aptitude (i.e., able to read, write and comprehend technical documentations and execute procedures).
- Proven ability around working cross functionally, focusing on meeting and tracking to schedules and embracing an interdependent work culture.
- Organisation Skills – Ability to manage multiple priorities and know when to escalate issues for resolution.
- Ability to think logically and be proactive under pressure.
- Ability to work as part of a team and on own initiative in a constructive manner.
- Flexible and self-motivated
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.
Beatriz Olmedo
Lead Recruitment Consultant
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