uniQure NV

Part of the Global IT team, the IT Business Analyst / Application Engineer of GxP Systems is an on-site all-around IT Professional, responsible for the implementation and support of IT enterprise quality systems and laboratory computer systems.. You are also responsible for the IT compliance to GxP regulations.. Executes risk-based strategy for Computer System Validation (CSV) lifecycle, including implementation, validation, maintenance.. Represents IT in collaboration with QA and other stakeholders (MFG, QC, R&D) to determine validation requirements.. Gather and analyzes the requirements for the IT systems used for Enterprise Quality Management, GMP, GLP, and overall GxP applications

application engineer

IT Business Analyst/ Application Engineer - GxP Systems

Location:

Lexington, 113 Hartwell Ave

Education level:

Bachelor / Graduate

Job category:

Information Technology corporate

Target start date:

1/22/2024

Work Location:

On-Site

Shift:

1st

uniQure is dedicated to bring innovative therapies or unmet medical needs to patients. In doing so each function in uniQure is directly or indirectly responsible for the lives of patients. This responsibility should be part of our day-to-day working life by (i) living up to high quality standards and (ii) by recognizing the sense of urgency in areas of high medical need.

Role & Place in the Organization

Part of the Global IT team, the IT Business Analyst / Application Engineer of GxP Systems is an on-site all-around IT Professional, responsible for the implementation and support of IT enterprise quality systems and laboratory computer systems. You are also responsible for the IT compliance to GxP regulations. You work with all business stakeholders, auditors, and IT partners to ensure the right solutions are delivered.

Key result areas (major duties, accountabilities and responsibilities)

IT GxP

Executes risk-based strategy for Computer System Validation (CSV) lifecycle, including implementation, validation, maintenance.

Represents IT in collaboration with QA and other stakeholders (MFG, QC, R&D) to determine validation requirements.

Executes Computer System Validation SOPs, protocols, and templates.

Ensures that the IT environment of uniQure is compliant to relevant quality standards.

Participates and provide artifacts and evidence per internal and external quality audits.

IT Projects

Gather and analyzes the requirements for the IT systems used for Enterprise Quality Management, GMP, GLP, and overall GxP applications

Responsible for execution of IT GxP SOP

IT Application Management per IT GxP SOP

Supports selected Key Business applications

User Access management per 21 CFR Part 11

Ensures Backup and Restore process

Controlled Change and Patch Management

Qualifications & Skills

BS or equivalent grade in Computer Sciences

A minimum of 3 years of working experience as IT professional

A minimum of 3 years of experience in Life Sciences

Core competencies

Excellent communication skills with the ability to interact with junior and senior members of the company

Reliable, consistent, and proactive

Ability to address multiple projects and adapt to changing priorities

Team-oriented and generous in sharing knowledge and enabling others

Self-motivated and passionate to learn and adopt new technology and methodologies

Customer Service oriented with attention to detail and quality

Strong technical background from within the IT industry with exposure to a wide range of (new) technologies

Experience in resolving multi-disciplinary or multifunctional/process problems

Ability to manage own workload

Capable of day-to-day problem solving and taking responsibility for decisions

Proficient in English, both oral and written

#J-18808-Ljbffr

START NEW SEARCH