LIMS Lab IT

LIMS Lab IT & CSV Specialist (Perm) – Onsite – PA

Award-winning CRO seeks a LIMS Lab IT & CSV Specialist for an onsite perm role. Ideal candidate will have 2+ years’ experience within main analytical lab instrumentation, computer systems validation and systems administration to include LIMS, ELN, LMS, CDS (systems similar to LIMS, Empower, and NuGenesis LMS). Individual must have GxP expertise as well. This person will provide lab application support while performing testing, implementations (systems and instrumentation), validation (CSV), data management, and user support. Opportunity affords a full-time perm opportunity with an organization offering competitive base compensation and benefits, and within a fully onsite role just west of Philadelphia. Please US Citizen or Green Card Work Authorization only. No third parties.

Requirements:

• US Citizen or Green Card Work Authorization; located within the US.
• Must be onsite in PA just west of Philadelphia – meaning relocation/local candidate.
• BS in Life Sciences.
• Expertise within major analytical lab instrumentation (LC/LCMS, Empower, etc.)
• A history performing Computer System Validation primarily for instruments/controls, and to include thorough understanding of GxP principles and methodology.
• Hands-on Administration and ideally configuration experience, within major lab systems to include LIMS, ELNS, LMS and more.
• Laboratory IT support expertise.

Responsibilities

• Assisting to ensure organizational global computer system validation program meets business/regulatory GxP requirements, while helping with client/FDA audits as needed.
• Providing validation support for Bioanalytical, DMPK, Biologics, Clinical and IT.
• Working to leverage validation efforts across multiple sites and enterprise systems.
• Providing extensive support, training and guidance for validation projects.
• Maintaining computer inventory for computer systems, software and instrumentation.
• Maintaining validated state of software systems through periodic review, change controls and implementation/upgrade reviews when necessary.
• Providing application support for lab systems to include LIMS, Sciex Analyst, IDBS ELN, QuickBase and eBinder.
• Resolving user issues and providing training as needed.
• Evaluating and implementing new software-based technologies.
• Supporting user account and application access controls.
• Managing/interacting with system vendors to escalate/resolve issues based on priority.
• Providing support, instrumentation qualification, and software validation, as well as enhancements and administration of various instrumentats and systems.
• Supporting lab software application configurations related to instrumentation.
• Completing various documentation in support of software changes/upgrades.
• Driving technological improvements and efficiency while always seeking opportunities for improvements within the areas of business and compliance.
• Contributing to change controls and procedures for various lab software.
• Coordinating, interfacing and hosting vendors on site when required.
• Providing training in software accessibility and functionality as needed.
• Ensuring software applications are validated according to 21 CFR Part11 compliance and constantly maintain that validated state.

Benefits

• Competitive Base comp depending upon individual skillset and level.
• Full Benefits to include Health, Dental and Vision.
• 401K with a 6% employer match at 100%.
• 4 weeks of vacation.
• 8 Holidays.
• Life Insurance
• Long & Short-term Disability
• Continuing Education Allowance
• Annual bonus based on performance
• Relocation assistance based on individual requirements and location.