Job Description

Specialist, Global LIMS Shared Services:Primary activities include but are not limited to:

• Responsible for LIMS Master Data Management that includes build/update of materials, sample plans, product specifications, analysis, calculations, process schedules, and other associated master data tables.
• Processes change controls for the LIMS system following applicable procedures.
• Prepare technical assessment of change, generate detailed system requirements, and initiate the change in an electronic repository (site or global change tool) and progress the change through its life cycle.
• Perform technical execution of changes based on the requirements and technical assessment forms provided by the site LIMS analysts.
• Work and collaborate with a distributed team including site-based LIMS analysts, GLIMS data librarians and other technical support teams at site and global (e.g., teams supporting SAP, Instrumentation, Empower, etc.) to implement change requests in a timely, standard, compliant and expedited fashion.
• Ensure the data build is per requirements and global static data standards. Responsible for driving and maintaining master data standardization and process harmonization across the GLIMS network.
• Provide second person review support for team members change control documents to source documents to ensure accuracy, compliance, integrity, and completeness.
• Provide technical support for Labware LIMS. Act as first level diagnostic of incidents and support end users in the management and timely resolution of technical incidents through the standard incident and problem management process.
• Experience with drafting and execution of test protocols, coordinates, and supports with site/global teams in confirmation of requirements, design, and build.
• Can work independently by prioritizing assigned work by the target due date, builds trust with customers by ensuring on time implementation of changes and drives results by overcoming obstacles.
• Hands on experience in LIMS basic coding for Analyses, Format Calculation, Subroutine.
• Can build mid to complex stored queries without much guidance.

Education, Skills & Experience:Qualifications

• Bachelors Degree or higher in Computer Science, BS Biology, Microbiology, Pharmacy, Chemistry, Engineering, or demonstration of the applicable experience.

Required Experience and Skills:

• A minimum of 5 years of Labware LIMS (v6 or higher) hands on experience in the pharmaceutical environment.
• Experience and demonstrated skills in master data management in Labware LIMS to support Release testing, Stability, Environmental Monitoring, and integration to external systems such as SAP, Empower and other instruments.
• Experience with use of LabWare LIMS including but not limited to knowledge of developing analyses, product specifications, environmental monitoring, lot manager, project manager, stability manager, storage location manager, standard and Reagent, and instrument manager.
• LIMS Basic experience to build or update component calculations and format calculations is required.
• Candidate must have knowledge of regulatory expectations for the manufacture and testing of vaccines, biological products, or sterile pharmaceutical products.
• Experience with System Development Life Cycle (SDLC) and Validation requirements ensuring compliance with regulatory requirements.
• Incumbent must complete technical assignments independently once specific objectives have been defined.
• Possesses a technical aptitude for computerized systems, analytics, and method evaluations.
• Flexible working hours (up to ~25%/week) are required to support collaboration with project teams in US East coast, especially during initial training period.

Preferred Experience and Skills:

• Familiarity with other compliant industry platforms/systems, electronic document management systems, change control systems.
• Ability to write test scripts and support execution of validation protocols adhering to SDLC.
• Use of databases, Oracle, data trending and basic coding capability (such as SQL, VBA).
• Development/validation of Microsoft Excel workbooks for GMP use.

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one anothers thinking and approach problems collectively for the common good. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.Current Employees applyCurrent Contingent Workers applySearch Firm Representatives Please Read Carefully
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