New 
OneLIMS EM Project Technical Writer
 Spectraforce Technologies | |
 United States, Pennsylvania, Swiftwater | |
 Jul 15, 2026 | |
|
Job Title: OneLIMS EM Project Technical Writer
Location: Swiftwater, PA (full onsite) Duration: 6 months * **Free parking available onsite** Position Summary The OneLIMS EM Project Technical Writer is responsible for supporting the on-time implementation of the OneLIMS EM global system for the Swiftwater, PA site. The individual will perform all tasks in an efficient, cGMP-compliant, and safe manner while supporting the alignment of quality processes and master data within the OneLIMS platform. The role requires the ability to work independently in a fast-paced, regulated environment with changing priorities. Primary Responsibility * Align the CPV (Continuous Process Verification) program with global standards. * Transfer process monitoring trend limits into OneLIMS. Key Responsibilities * Design, develop, and maintain technical documentation. * Edit quality documents, including SOPs, guidelines, and Validation Master Plans (VMPs), ensuring compliance with regulatory requirements. * Create training materials, including presentation slides and supporting documentation. * Support future-state process mapping activities. * Organize, track, and plan master data review activities. * Track and manage project-specific deliverables. * Perform all work in compliance with cGMP, safety, and quality standards. Required Qualifications * Bachelor's degree in Science or Engineering required. * Master's or PhD candidates are welcome. * Minimum of 2 years of relevant experience (additional years of experience will also be considered). * Experience with LIMS/iLMS. * Ability to work independently with minimal supervision. * Strong preference for experience within the **biotechnology or pharmaceutical industry. * Experience working in a GMP/cGMP-regulated environment. * Proficiency with Microsoft Word, Excel, PowerPoint, Visio, and Outlook. * Excellent written and verbal communication skills. * Strong interpersonal, organizational, and information-gathering skills. * Ability to work effectively in a collaborative team environment. Preferred Qualifications * Familiarity with **OneLIMS**. * Experience with **Qualipso**. * Experience with **CPV (Continuous Process Verification)** methodologies. * Experience with **Sequel**. | |