Job Title: Technical Writer II
Location: Swiftwater, PA (on-site)
Contract: 6-months
Schedule: Monday - Friday; 8 AM - 4:30 PM
Pay Rate Max: $54 per hour
Sanofi's contingent workforce program, FLEXT Direct, is seeking a Technical Writer II for a 6-month contract.
We are seeking a detail-oriented and technically proficient specialist to support the on-time implementation of a global Laboratory Information Management System (LIMS) for environmental monitoring at our Swiftwater, PA site. This role is central to aligning the Continued Process Verification (CPV) program with global standards and transferring process monitoring trend limits into the new system. The ideal candidate thrives in a fast-paced, high-stress environment, demonstrates adaptability in the face of shifting priorities, and operates with a strong commitment to cGMP compliance and workplace safety. This position requires a collaborative team player with exceptional communication skills and a keen eye for detail across both technical documentation and data management activities.
Responsibilities:
Design, develop, and maintain required technical documentation in support of system implementation
Assist with editing and updating quality documents including SOPs, guidelines, and validation master plans to ensure regulatory compliance
Create training slides and supporting content for end-user onboarding and system adoption
Support future state process mapping activities to align workflows with global standards
Organize, track, and plan master data review activities across project milestones
Track and manage project-specific deliverables to ensure on-time completion
Align the CPV program with global standards and facilitate transfer of process monitoring trend limits into OneLIMS
Complete all required Safety and Compliance training and associated training modules
Skills:
Proficiency with quality management applications such as Veeva and LIMS platforms
Strong working knowledge of Microsoft Word, Excel, PowerPoint, Visio, and Outlook
Excellent verbal and written communication skills with the ability to convey complex technical information clearly
Sound interpersonal and information-gathering skills with the ability to collaborate effectively in a team environment
Ability to adapt quickly to changing priorities in a dynamic, high-pressure setting
Strong organizational and project tracking abilities
Familiarity with OneLIMS, Qualipso, and CPV programs is a plus
Experience:
Minimum of 2 years of related experience in a technical writing, data management, or quality systems role
Prior work experience in a Good Manufacturing Practices (GMP) environment
Experience supporting LIMS implementation or quality system projects preferred
Education:
This is a unique opportunity to play a pivotal role in a high-visibility global systems implementation that directly impacts quality and compliance operations at a leading life sciences site. You will gain hands-on experience with cutting-edge quality platforms, collaborate with cross-functional teams, and contribute meaningfully to initiatives that support the safety and efficacy of critical healthcare products — all while advancing your career in a dynamic and innovative environment.