Biopharmaceutical Software Informatics Jobs (NOW HIRING)

GENERAL SUMMARY 

In this role, you will work both collaboratively within cross-functional teams - including colleagues, consultants, vendors, and MSPs - and independently to support day-to-day operations and project-based initiatives. The primary focus of the role is managing daily operational activities, including Tier 1 and Tier 2 IT Helpdesk support for end users and customers. Responsibilities include supporting lab equipment and applications (GMP and non-GMP), troubleshooting hardware and software issues, performing computer system validation activities (including change controls, validation execution, NCRs, AIRs, and CAPAs), maintaining data integrity and compliance, and administering system configuration, access management, security patching, and data backup processes. The ideal candidate is adaptable, service-oriented, and brings a broad technical skillset to effectively support evolving business needs.  Hybrid schedule acceptable with a desire for 3-4 days onsite weekly.   

 MAJOR DUTIES & RESPONSIBILITIES: 

• Execute & comply with 4DMT SDLC, Change, Access, Inventory, & operational management procedures for businesscritical applications & platforms. 

• Support evaluation, pilot testing, selection, & ongoing management of IT vendors & partners aligned to business & compliance requirements. 

• Lead or support validation of computerized systems & laboratory instruments, including installation, configuration, troubleshooting, & documentation (SOPs, IQ/OQ/PQ). 

• Ensure ongoing data integrity, backup, & regulatory compliance for GMP laboratory & manufacturing systems. 

• Provide technical input & support for Investigations, Change Controls, CAPAs, decommissioning, & audit readiness activities. 

• Participate in or lead Periodic Reviews, User Access Reviews, & Audit Trail Reviews for GMP systems. 

• Execute & support UAT activities, collaborating with IT & business teams on issue resolution. 

• Deliver handson operational support for QC & Manufacturing instrument systems, including break/fix support & reliability issues in validated & production environments. 

• Manage user account provisioning & deactivation in compliance with access control SOPs. 

• Other duties as assigned, nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time 

 QUALIFICATIONS: 

Education: 

• Bachelor's degree in Information Technology, Computer Science, Life Sciences, or a related field with at least 5+ years of relevant experience in a laboratory environment or biotech/pharma setting; or 

• Master's degree with 3-5+ years of relevant experience 

 Experience: 

• Strong operational knowledge of laboratory IT environments, including instrument connectivity & client/server architectures. 

• Proficiency in Windows OS administration (registry, system files, security, local accounts & policies). 

• Working knowledge of network technologies (VLANs, firewalls, security protocols, instrument LANs). 

• Familiarity with virtualization platforms (e.g., VMware, Citrix VDI). 

• Experience supporting validated systems in a regulated GxP environment is required. 

• Knowledge of 21 CFR Part 11, Annex 11, data integrity, and CSV process 

• Familiarity with broad range of lab instrumentation and Enterprise IT solutions used in Biopharma, e.g., LC systems (Waters/Agilent), AKTA, SoftMaxPro, Geneious, ELN/LIMS (Sapio), Imaging Systems, Bioreactors, Plate readers, Sequencers, etc. 

 Travel: None 

 Physical Requirements and Working Conditions: 

• Physical Requirements - Sedentary work: Exerting up to 10 pounds of force occasionally and/or a negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects, including the human body. Sedentary work involves sitting most of the time. Jobs are sedentary if walking and standing are required only occasionally and all other sedentary criteria are met. 

Hourly compensation range: $47.00 - 60.00/hr

Please note, the base salary compensation range and actual salary offered to the final candidate depends on various factors: candidate's geographical location, relevant work experience, skills, and years of experience.