GMP IT Infrastructure and System (Sr) Engineer
$94,992–$151,688 year
On-site · Rockville, Maryland, United States
Job Summary
GMP IT Infrastructure and System (Sr) Engineer responsible for establishing and maintaining GMP Computer System, Data Integrity and Compliance; manage day-to-day IT operations; design, implement, and maintain GMP IT system infrastructure; set up and administer lab instruments (including Active Directory, user groups, access); identify and implement software/hardware/cloud solutions for data backup; build disaster recovery and business continuity plans; collaborate with internal partners to deliver IT programs; ensure regulatory compliance (data security, 21 CFR Part 11, Annex 11, GAMP5) and support Computer Systems Validation (CSV); support Quality with change actions and SOP generation; oversee IT suppliers and asset management; contribute to a fast-growing biotech/pharma environment at AbelZeta with a Rockville, MD base.
Required Qualifications
- Bachelor’s degree in technology, engineering or computer science
- At least 5 years of relevant and progressive IT experience
- Familiarity with cell therapy laboratory instrument software, such as FACSLyric
- Experience in biotech, pharma or life sciences manufacturing and GMP environment
- Expertise with implementing, configuring, and testing IT 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 (operation, change, upgrade, migration, archiving, etc.)
- Experience in internal and external audit support of computerized systems
- Strong communication, collaboration, and problem-solving skills
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