GMP IT Infrastructure and System (Sr) Engineer

AbelZeta Inc • Rockville, MD

3d • $94,992 - $151,688 • Onsite

About The Position

AbelZeta Inc. is a clinical-stage biopharmaceutical company focused on the development of novel immunotherapy products. AbelZeta operates a state-of-the-art facility in Rockville, Maryland with five GMP rooms and a QC laboratory in order to augment its global research and development capabilities and to support clinical development of multiple cell therapy platform technologies. We are on a rapid growth trajectory and have a highly energized and accomplished team driving to new frontiers of care for cancer and autoimmune disease patients. We are seeking a GMP IT Infrastructure and System (Sr) Engineer to join our team. He or she will play a pivotal role in establishing and maintaining GMP Computer System, Data Integrity and Compliance and network security procedures. This role will be also responsible for managing the day-to-day IT operations activities.

Requirements

• Bachelor’s degree in technology, engineering or computer science
• At least 5 years of relevant and progressive experience driving process improvement and systems implementations and leading projects from design, development to implementation of IT solutions.
• Familiarity with cell therapy laboratory instrument software, such as FACSLyric
• Experience in biotech, pharma or life sciences manufacturing and lab with an understanding of what is required in a GMP environment is a must.
• Expertise with implementing, configuring, and testing solutions.
• Knowledge of 21 CFR Part 11, Annex 11, GAMP5, data integrity, and Computer systems Validation process
• Experience in the life cycle management of computerized systems, including but not limited to: operation, change, upgrade, migration, file archiving, periodic review, retirement management, etc.
• Experience in the internal and external audit support of computerized systems

Nice To Haves

• Self-starter with a go-getter attitude and the ability to proactively identify and solve problems.
• Highly motivated with a strong sense of ownership and accountability.
• Strong communication skills to effectively support both technical and non-technical users.
• Empathetic and professional approach, with the ability to remain calm and supportive under pressure.
• Team-oriented with the ability to collaborate across office and lab functions.

Responsibilities

• Design, implement, and maintain GMP IT system infrastructure.
• Manage day-to-day IT operations, partnering with vendors for support and ensure office internet/wifi reliability.
• Set up and administration of lab instruments (including implementation of active directory, setting up user groups, user access, configuring systems, etc)
• Identifies and implements software, hardware, and cloud solutions for data backup processes and other processes as needed
• Build and maintain business continuity and disaster recovery strategies to minimize downtime and ensure rapid recovery of critical systems
• Work with internal partners to understand strategy and business challenges to proactively recommend IT solutions and to deliver key programs and projects for the site.
• Ensure compliance of company IT operations with the regulations and standards including but not limited to data security.
• Provide IT support for computer system validation (CSV) to ensure data integrity per FDA regulation.
• Works with Quality department to present change plans, change actions, and close assigned workflows
• Assist with SOP generation as needed including, but not limited to, administration SOPs and access management procedures
• IT suppliers management: overseeing the selection and onboarding of IT suppliers, monitoring performance metrics and cost, etc
• IT fix assets management: tracking inventory of hardware, software, and network components and optimizing asset utilization to reduce costs and prevent redundancy, etc.
• Other duties as assigned.

Benefits

• 100% company paid medical, dental, vision, life Insurance, short-term and long-term disability insurance
• Competitive company 401k match
• Paid holidays, sick leave, and annual leave

What This Job Offers

• Job Type: Full-time
• Career Level: Senior