Technical Writing Specialist

Need someone with both strong technical writing skills and and the ability to execute validations in an aseptic environment. Please look for candidates accordingly.
Bachelor's degree required.

Knowledge, Skills & Abilities:
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.
Process oriented with solid critical thinking skills; adaptive and able to develop new/improved strategies, approaches, and procedures.
Strong understanding of cGXP requirements and good documentation practices relating to systems, equipment and instrumentation within the pharmaceutical industry.
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.
Ability to interact effectively with cross-functional groups.
Strong ability to organize assigned tasks in a high paced environment and concurrently monitor tasks / assignments with others that may impact timely completion. Ability to effectively manage multiple tasks and activities simultaneously.
Strong written and verbal communication skills, including solid presentation skills. Proficient at writing well-formulated emails and reports. Ability to follow oral and written instructions, read and interpret engineering manuals/drawings relevant to the assigned task. Ability to effectively communicate with employees, contractors and vendors.
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.

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