TSR is a premier National U.S. Staffing company with over 50 years of staffing excellence.
Our client, a leading pharmaceutical company is hiring a Technical Writer. Please ONLY local candidates to Warren NJ.
Bachelor's degree required. Strong understanding of cGXP requirements and good documentation practices relating to systems, equipment and instrumentation within the pharmaceutical industry is a MUST. MUST have strong technical writing skills and the ability to execute validations in an aseptic environment.
Work Location: Warren NJ
Pay: $50-51/hour W2
- Supports the successful implementation of laboratory equipment and systems at multi-use sites through interaction with internal customers and external service providers
- The incumbent in this role, contributes to the completion of milestones associated with facility, utility, and equipment qualification
- Must have excellent technical writing skills and proficiency with Microsoft Word formatting functions; ability to efficiently create technically accurate documents for system lifecycle deliverables in alignment with the site validation program; highly attentive to spelling, grammar, punctuation, and overall document quality
- Experience writing Standard Operating Procedures, Work Instructions/Practices, and Risk Assessments for pharmaceutical production processes and/or manufacturing equipment, systems, utilities, and facilities
- Experience authoring and executing commissioning/qualification/validation deliverables including plans, system requirements, protocols, traceability matrices, and summary reports
- Experience writing protocol deviations, investigating out of specification results, performing corrective and preventive actions, and executing change controls
- Strong computer skills in Microsoft Office Suite – Word, Excel, Outlook and Teams, and the ability to learn new software as required
- Preferred experience with Blue Mountain Regulatory Asset Manager and Veeva Vault applications
- Author and execute commissioning/qualification/validation deliverables including assessments, plans, system requirements, protocols, traceability matrices, and summary reports for manufacturing equipment, systems, utilities, and facilities
- Author protocol deviations, investigate out of specification results, perform corrective and preventive actions, and execute change controls
- Develop written procedures for operation, cleaning, and maintenance of equipment and systems