USA- USA-Technical Writer II (IT)
Location: Swiftwater, PA
Duration: Contract till Jan 2027 with possibility to extend
Shift: 1st, Shift M-F 8am-4:30pm est Background
Notes:
Shift: 1st Work Schedule: M-F 8am-4:30pm est Background Check Package: US/Canada: Standard Background Check Pre-ID Candidate Name: (No Value) Pre-ID Supplier Name: (No Value) Comments: 06/30/2026 05:32 PM - Local candidates only, full onsite No extension at this time Free parking onsite MS, PHD candidates welcomed. Additional years of experience will be accepted.
Must have Experience:
• Min Bachelor’s degree and 2+ years of relevant experience
• LIMS, iLMS
• Ability to work Independently
• Strongly Preferred biotech pharma exp
Nice to Have:
• Qualipso
• Experience with methodologies: CPV, Continuous Process Verification have
• Sequel
Job Description:
Role: QC OneLIMS Data Setup Specialist
Description The OneLIMS EM project technical writer is responsible for supporting on-time implementation of 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.
Primary Responsibility:
alignment of CPV program with global standards & transfer of Process monitoring trend limits to OneLIMs
KEY RESPONSIBILITIES:
• 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 mange project specific deliverables
QUALIFICATIONS:
• 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. Education: BS in science or engineering
Preferred: familiarity with One LIMs, Qualipso, and CPV programs.
