Technical Writer

Job Description: Technical Writer II

Location: Branchburg, NJ 08876 (Primarily Onsite)

Duration: 6+ Months

Role Overview:

We are seeking a highly proactive and engaged Technical Writer II to support our manufacturing operations and Supply Chain functions. In this role, you will go beyond traditional documentation; you will actively drive the change control process, align with various stakeholders, and ensure GMP-related documentation and CAPA closures are executed accurately and efficiently.

The ideal candidate takes ownership of the documentation lifecycle, is comfortable gathering inputs from Subject Matter Experts (SMEs), and possesses the initiative to push tasks through to completion in a fast-paced, regulated pharmaceutical environment.

Key Responsibilities:

• Proactive Stakeholder Management: Actively partner with Supply Chain SMEs, Quality teams, and other stakeholders to understand required changes, reach alignment, and drive the documentation process through completion.
• Documentation Development: Author, revise, and maintain GMP documentation including SOPs, Work Instructions, Job Aids, specifications, forms, and Change Controls.
• Change Control & CAPA Management: Compile supporting documentation, coordinate change proposals, and facilitate CAPA closures. Ensure all change management requirements for GMP documentation are strictly met.
• Process Ownership & Follow-Up: Take the initiative to schedule meetings, gather inputs, and relentlessly follow up with reviewers and approvers to ensure timely completion of documentation and change control activities.
• Standardization & Quality Assurance: Develop and maintain standards for the content and formatting of SOPs. Ensure documents are logically organized, minimizing gaps and duplication while meeting or exceeding Quality/compliance expectations.
• Continuous Improvement: Actively participate in Operations-related process improvement initiatives, developing communications and leveraging data to optimize documentation workflows.

• Education: Bachelor's degree in a scientific/technical discipline (or 5+ years of equivalent relevant experience). Note: Candidates with a Master's degree are welcome to apply if they are comfortable with the scope and compensation of this role.
• Experience: 3 to 6 years of relevant technical writing experience within a regulated manufacturing environment (Pharmaceutical, Biotech, or Medical Device) would be ideal.
• Documentation Expertise: Proven, hands-on experience writing manufacturing/operational procedures (SOPs, Work Instructions, Job Aids) and managing Change Controls. (Note: Experience limited strictly to Computer Systems Validation is not sufficient for this role).
• Behavioral Competencies:
  
  
  
  • Highly Proactive: Must be a self-starter who takes initiative rather than waiting for instructions.
  • Ownership & Drive: Ability to independently coordinate activities, resolve roadblocks, and drive documentation to final approval.
  
  
  
  
• Communication Skills: Exceptionally strong written and verbal English communication skills. Ability to communicate effectively across all levels of the organization.
• Technical Proficiency: Must be proficient with Microsoft Office applications (Word, Excel, Access, PowerPoint). Familiarity with quality control, change control, and advanced document management systems.

• Direct experience working within Supply Chain Operations, Material Management, Logistics, or Planning.
• Exposure to a combination of IT and Quality Control (QC) environments.
• Previous training or meeting facilitation experience.