Sr. GMP IT Operational Technology Group (OTG) Engineer

Job Description

Job Description

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 Operational Technology Group (OTG) 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. 

Responsibilities and Duties:

• Design, implement, and maintain GMP IT infrastructure, including servers, networks, storage, Active Directory, and endpoint devices.
• Manage the lifecycle of GMP computerized systems, including system inventory, ownership, validation status, change control, periodic review, and retirement.
• Lead and support Computerized System Validation (CSV) activities, including risk assessments, validation status, periodic review, upgrades, change management, archival, and retirement.
• Administer access controls, including user provisioning, privileged access, audit logging, and periodic access reviews.
• Develop, implement, and maintain IT procedures and documentation for GMP operations, including access management, backup and recovery, incident management, configuration management, audit trail review, and data integrity.
• Manage GMP data backup, disaster recovery, data archiving, and restore testing to ensure business continuity and regulatory compliance.
• Partner with Quality, Manufacturing, IT, and Facilities to implement compliant IT solutions and support system changes.
• Support audits, inspections, deviations, CAPAs, and change controls.
• Drive continuous improvements in IT infrastructure, cybersecurity, computerized systems, and GMP compliance.
• Other duties as assigned. 

Qualifications and Requirements:

• Bachelor’s degree in technology, engineering or computer science
• Experience supporting GMP computerized systems in a biotechnology, pharmaceutical, or regulated manufacturing environment is required.
• 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 

• 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 

Why You Should Join AbelZeta

• Join a high-growth and fast-paced organization.
• Defined career path and annual performance review and feedback process.
• Comprehensive Benefits Plan, including 100% company paid medical, dental, vision, life Insurance, short-term and long-term disability insurance, and more!
• Competitive company 401k match.
• Paid holidays, sick leave, and annual leave.

AbelZeta is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. AbelZeta validates right to work using E-Verify. Salary at AbelZeta is determined by various factors, including but not limited to location, the individual’s particular combination of education, knowledge, skills, competencies, and experience, as well as contract-specific affordability and organizational requirements. The estimate displayed represents the typical salary range for this position and is just one component of AbelZeta’s total compensation package for employees.