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IM - QC Systems Analyst

Location Cork, Ireland
BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options. BioMarin will continue to focus on advancing therapies that are the first or best of their kind.

By providing a foundation for all operations company wide, BioMarin’s General and Administrative teams support our mission of providing first and best in class therapeutics to patients who live with rare diseases. Our teams include groups such as finance, legal, human resources, corporate compliance and ethics, and information technology. Come join our team and make a meaningful impact on patients’ lives.

Senior QC Application Support Engineer

This position reports to the Manager, MFG Lab Systems in the Information Management department and will be responsible for the implementation of validated computer systems throughout their lifecycle for the QC department with a particular focus on QC Enterprise applications (e.g. LabWare LIMS, MODA, Empower, WinKQCL); similar support for QC benchtop instruments is also required.

The Senior QC Application Support Engineer requires in depth knowledge of QC Enterprise applications and will perform administration, support, configuration, development, and routine Master Data maintenance.  The ability to script in SQL and/or LIMS Basic is a plus.  The successful candidate will  coordinate across functional areas and ‘wear many hats’ in a fast paced environment.

• Analysis and Solution Definition
• Perform Business System Analysis and technical lead duties for implementation projects
• Support the validation of applications including but not limited to risk assessments, technical guidance, discrepancies, Use Cases, URS, UAT, Qualification Reports, template verifications, Baseline configurations, Change Control, SOPs, System Retirement Plans & Protocols, validation reports.
• Maintain current knowledge of industry standards and regulatory requirements for computerized systems
• Identify and implement improvements to the IT applications where appropriate
• Draft and edit process flow diagrams
• Propose technical solutions and architectures
• Develop User Requirements working closely with the Business Process Owner(s) and Business Analysts
• Develop Functional Requirements and Configuration Specifications

Technical Recommendation and Testing
• Lead User Acceptance Testing/Conference Room Pilots, workshops and documents gap analysis
• Manage iterative development of system as needed to ensure system meets business needs
• Work closely with CSV personnel to develop risk appropriate testing strategy.
• Review and edit validation deliverables including but not limited to: Risk Assessment, IQ, OQ, PQ, MQ, regression testing, and Retirement Plans,
• Drafts and Executes Validation protocols as appropriate

Project Execution
• Enforcement of project deadlines and schedules, as required.
• Drafting Project Specific deliverables including but not limited to Project Implementation Plan, meeting agendas, minutes, Change Requests, and presentations, as required.
• Communicates and applies project standards.
• Manages resources in accordance with project schedule.
• Promotes positive attitude among team members
• Promotes best practices and standards, and reviews deliverables to ensure highest standard of delivery

System Support & Lifecycle management
• Identify, track and resolve application issues in a timely manner and perform root cause analysis.
• Develop and document appropriate computer system procedures and forms for use in various administrative processes to ensure the system continues to meet the organization’s needs.
• Provide key input into strategic roadmap for new functionality or upgrades
• Supervise and participate in the preparation of Standard Operating Procedures and training materials for system users.
• Train staff on proper procedures for using software systems as required.
• Investigate area user needs and propose creative solutions
• Master Data creation and maintenance
• Defend the system as SME during audits
• Host Super User meetings to gather new enhancement requests, identify training opportunities, and communicate status updates to the key users

Minimum of 5 years experience supporting and implementing Enterprise application(s) as an Administrator (e.g., LIMS, Empower)
Firm understanding of computer system validation, GMP predicate rules, 21CFR Part 11/EU Annex 11, and Data Integrity concepts
Clear verbal and written communication skills to provide customers with a positive experience

LabWare LIMS/ELN configuration skills, LIMS Basic, knowledge of relational databases and SQL queries, Crystal Reports development skills
Lonza MODA administration and configuration skills
Empower administration and configuration skills
Basic programming knowledge in any language
Trackwise experience
Experience with HP ALM or equivalent software testing/requirements tools
Experience with application deployment methodologies in a regulated environment (GAMP 5, Risk Analysis, Waterfall, Agile & Rapid development methodologies, etc.)
GxP benchtop instrument experience
ITIL Certification

Bachelor’s Degree preferably in Computer Science or Life Sciences.  Equivalent experience may be considered.
LabWare LIMS Admin Certification or equivalent is highly desired.

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.

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We treat rare diseases, and that gives us rare opportunities. Chris Brodeur, Director, Corporate Compliance
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