GXP Lab Computing Analyst - W2

Introduction

The GXP Lab Computing Analyst will play a crucial role in ensuring compliance and efficiency in laboratory computing systems within the biotechnology and pharmaceutical industry. This individual will be responsible for analyzing business requirements, designing and implementing software solutions, and providing support for GxP and GMP processes.

Responsibilities

• Analyze business requirements and gather necessary information for software development and testing.
• Design, implement, and maintain laboratory computing systems in compliance with GxP and GMP standards.
• Provide technical support and troubleshooting for lab workflows, sample management, and robotic systems integration.
• Collaborate with cross-functional teams to ensure operational KPIs and metrics are tracked effectively.
• Stay informed about industry regulations and standards governing technical solutions in the biopharmaceutical sector.

Requirements

Required Skills:

• Bachelor’s/Master’s degree in Pharmaceutical, Bio-technology, Bio-medical, or Chemical.
• Minimum of 4 years of relevant experience, including at least 1 year in software development and testing.
• Strong analytical and interpersonal skills with a proven track record in system design and implementation.
• In-depth understanding of Bio/Pharma industry processes such as drug discovery, clinical study planning, and lab workflows.
• Familiarity with operating systems (Unix, Windows, MVS), software methodologies, and development processes.
• Proficiency in MS Office tools (Word, Excel, PowerPoint) and productivity platforms like Visio, MS Project, or SharePoint.

Preferred Skills:

• Experience with robotic systems integration and qualification.
• Knowledge of change control management and risk management principles.
• Familiarity with international regulations such as GLP, GMP, and 21 CFR Part 11.