Regulated IT Professional
2 weeks ago
Join Replimune, Inc. as a Regulated IT Professional and contribute to the development of innovative oncolytic immunotherapies. This role involves working with GxP-compliant systems, collaborating with cross-functional teams, and ensuring compliance with regulatory requirements.
The successful candidate will be responsible for managing GxP-connected computer systems, ensuring their optimal performance, and identifying and resolving hardware and software issues related to GxP and lab-connected computer systems. The primary objective will be to ensure that these systems remain operational, audit-ready, and function within regulatory and quality guidelines.
About You:
We are looking for a highly motivated individual with 3-5 years of experience working with GxP-compliant systems in a biotech or pharmaceutical environment. A Bachelor's degree in Computer Science, Information Technology, or equivalent experience is required. Strong knowledge of GxP, 21 CFR Part 11, and GAMP5 regulations is essential. Experience working with audit trails, electronic record management systems, and familiarity with FDA audits is also desired.
Key Responsibilities:
- Collaborate with cross-functional teams to ensure GxP-compliant systems meet regulatory requirements.
- Identify and resolve hardware and software issues related to GxP and lab-connected computer systems.
- Develop and maintain SOPs, user manuals, forms, and device qualification documents.
Salary and Benefits:
This role offers a competitive salary of $130,000 - $160,000 per annum, depending on experience, and a comprehensive benefits package including health insurance, retirement savings plan, and paid time off. We are an equal opportunities employer and welcome applications from diverse candidates.
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