Technical Writer II; IT

The Fountain Group is currently seeking a QC OneLIMS Data Setup Specialist for a prominent client of ours. This position is located at Swiftwater, PA.

• Type:
  Onsite – Local Candidates Only
• Location:
  
  1 Discovery Dr, Swiftwater, PA 18370
• Duration: 6 Months (Contract)
• Pay: $54/hr on W2
• W2 candidates only, no C2C

We are seeking a QC OneLIMS Data Setup Specialist to support the implementation of a global OneLIMS Environmental Monitoring (EM) system in a GMP-regulated manufacturing environment. This role will focus on OneLIMS master data setup, CPV program alignment, process monitoring data migration, technical documentation, and quality system support. Candidates with an MS or PhD are welcome to apply; additional years of experience may be considered in lieu of advanced education.

• Configure and maintain OneLIMS master data to support Environmental Monitoring implementation.
• Align Continuous Process Verification (CPV) program data with global standards.
• Transfer process monitoring trend limits into OneLIMS.
• Develop and maintain technical and quality documentation, including SOPs, validation documents, and related records.
• Create training materials and documentation for system implementation.
• Support future-state process mapping and quality system workflows.
• Track master data reviews and project deliverables.
• Ensure compliance with cGMP and quality system requirements throughout implementation.

• Bachelor's degree in Science, Engineering, or a related discipline required.
• Master's or PhD candidates are encouraged to apply.
• Minimum 2+ years of relevant industry experience.

• Hands‑on experience with OneLIMS/LIMS or similar Laboratory Information Management Systems required.
• Experience with quality applications such as Veeva and LIMS platforms required.
• Experience working in biotechnology or pharmaceutical manufacturing environments required.
• Knowledge of cGMP/GMP regulations and quality documentation required.
• Technical documentation including SOPs, validation documentation, and training materials required.
• Master data management and process monitoring support required.
• Experience supporting laboratory or quality system implementations required.
• Ability to work independently in a fast‑paced regulated environment required.

• Experience with Qualipso.
• Knowledge of Continuous Process Verification (CPV) methodologies.
• Familiarity with OneLIMS Environmental Monitoring (EM) implementations.
• SQL (Sequel) experience for data analysis and reporting.
• Experience with process mapping and project deliverable tracking.