Technical Writing Specialist - TechDigital Corporation
Warren, NJ
About the Job
1. PURPOSE AND SCOPE OF POSITION:
The Technical Writing Specialist 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. With minimum supervision and given general instructions, this individual independently carries out routine tasks and functions, and uses basic analytical skills to recognize and solve common problems of limited scope. As a developing team player, the incumbent interacts with their immediate supervisor and personnel within their own work group to achieve team goals while building trust and collaborative relationships outside the immediate organization.
2. REQUIRED COMPETENCIES:
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, punctation, 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.
• Preferred experience authoring and executing commissioning/qualification/validation deliverables including plans, system requirements, protocols, traceability matrices, and summary reports.
• Preferred 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.
3. DUTIES AND RESPONSIBILITIES
• Develop written procedures for operation, cleaning, and maintenance of equipment and systems.
• Author risk assessments for equipment, systems, facilities, and utilities.
• Perform gap assessments for revisions to the site validation program and the corresponding impact of those changes to all applicable site level functional areas and relevant procedures.
• Create all documents in compliance with Client standards and policies.
• Provide excellent customer service and support. Maintain a positive relationship with all team members and site customers while promoting a positive team environment.
4) EDUCATION AND EXPERIENCE
a. BA/BS degree, Bachelor of Science degree required
b. Minimum 5 years of experience in technical writing, with 3 years of technical writing experience in the pharmaceutical industry
The Technical Writing Specialist 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. With minimum supervision and given general instructions, this individual independently carries out routine tasks and functions, and uses basic analytical skills to recognize and solve common problems of limited scope. As a developing team player, the incumbent interacts with their immediate supervisor and personnel within their own work group to achieve team goals while building trust and collaborative relationships outside the immediate organization.
2. REQUIRED COMPETENCIES:
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, punctation, 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.
• Preferred experience authoring and executing commissioning/qualification/validation deliverables including plans, system requirements, protocols, traceability matrices, and summary reports.
• Preferred 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.
3. DUTIES AND RESPONSIBILITIES
• Develop written procedures for operation, cleaning, and maintenance of equipment and systems.
• Author risk assessments for equipment, systems, facilities, and utilities.
• Perform gap assessments for revisions to the site validation program and the corresponding impact of those changes to all applicable site level functional areas and relevant procedures.
• Create all documents in compliance with Client standards and policies.
• Provide excellent customer service and support. Maintain a positive relationship with all team members and site customers while promoting a positive team environment.
4) EDUCATION AND EXPERIENCE
a. BA/BS degree, Bachelor of Science degree required
b. Minimum 5 years of experience in technical writing, with 3 years of technical writing experience in the pharmaceutical industry
Source : TechDigital Corporation
