We are seeking a Senior Technical Writer to join our team in the pharmaceutical industry. This role focuses on leading the creation, review, and management of technical documentation related to process equipment, P&ID and User Requirement Specifications (URS). The ideal candidate will have a strong engineering or technical background with proper experience in pharmaceutical process documentation and compliance with industry regulations.
Key Responsibilities:
* Lead the development and maintenance of technical documents such as User Requirement Specifications (URS), Standard Operating Procedures (SOPs), equipment manuals and (future) validation documents.
* Provide expertise in interpreting Piping & Instrumentation Diagrams (P&IDs), technical drawings, and process flow diagrams to ensure precision and clarity in documentation.
* Collaborate closely with all kinds of stakeholders (client, the Engineering firm, subcontractors, machine builders, ...)
* Oversee the review, revision, and approval processes of technical documentation to align with cGMP)
* Ensure all documentation is clear, structured, and compliant with both internal and external regulatory requirements.
* Manage document control processes, ensuring version accuracy, accessibility, and compliance.
* Act as the primary author and reviewer for User Requirement Specifications (URS), ensuring alignment with operational and regulatory needs.
* Mentor and guide junior technical writers in best practices and industry standards.
Requirements:
* Bachelor's or Master's degree in Engineering, Life Sciences, Technical Writing, or a related field. Advanced degrees or certifications are a plus.
* 5+ years of experience in technical writing, engineering, or process documentation within a pharmaceutical, biotech, or manufacturing environmen
* Extensive experience with process equipment, P&ID interpretation, and pharmaceutical manufacturing processes.
* Deep understanding of cGMP, FDA, and other industry regulations.
* Proficiency in Microsoft Office (Word, Excel, Visio) and experience with document management systems (DMS).
* Strong technical writing, editing, and communication skills, with an emphasis on accuracy and compliance.
* Ability to work independently, manage multiple projects, and collaborate with cross-functional teams.
* Demonstrated experience in developing URS documents and validation documentation
Preferred Qualifications:
* Strong background in validation processes and compliance documentation.