Technical Writer – LIMS​/GMP Documentation; Pharma

Job Title - OneLIMS EM project technical writer

Location:
Swiftwater, PA 18370

Duration:
Contractual till Mar 2027 with the possibility of extension

The OneLIMS EM project technical writer is responsible for supporting on‑time implementation of the OneLIMS EM global system for the Swiftwater, PA site. The candidate must perform tasks in an efficient, cGMP compliant, and safe manner. Success in this position requires the individual to be adaptable and react quickly to changing priorities in a high‑stress environment. The candidate is required to complete Safety and Compliance training and associated training modules.

• Design, develop, and update required technical documentation.
• Assist with the editing of quality documents (SOP's, guidelines, validation master plans, etc.) to ensure compliance with regulatory requirements.
• Create training slides and content.
• Support future state process mapping.
• Organize, track and plan master data review.
• Track and manage project specific deliverables.

• QC (quality control) activities, editing of quality documents (SOP's, guidelines, validation master plans, etc.).
• LIMS systems (e.g., Lab Vantage, iLMS, Sequel, or related systems).
• Experience deploying digital systems (e.g., Lab Ware, LIMS).
• Pharmaceutical or biotech environments (e.g., Veeva, GMP).
• Bachelor's Degree required.
• Prior experience with quality applications, such as Veeva, LIMS.
• Prior experience with MS Word, Excel, Powerpoint, Visio and Outlook.
• Prior work experience in a good manufacturing practices (GMP) environment.
• Must possess sound interpersonal and information gathering skills, be able to relate well to others, and have the ability to work in a team environment, effectively interacting with others.
• Excellent verbal and written communication skills.
• Minimum of 2+ years of related experience.