We are seeking a Junior Technical Writer to join our team in the pharmaceutical industry. This role focuses on receiving, summarizing, updating, and managing technical documentation related to process equipment, manuals, P&ID's, ... and creating User Requirement Specifications (URS). The ideal candidate will have an engineering or technical background with strong writing skills and an interest in developing expertise in pharmaceutical process documentation.
Key Responsibilities:
* Develop and maintain technical documents such as User Requirement Specifications (URS), Standard Operating Procedures (SOPs), equipment manuals, ...
* Interpret and work with Piping & Instrumentation Diagrams (P&IDs), technical drawings, and process flow diagrams to ensure accuracy in documentation.
* Collaborate with Engineering to gather technical details and ensure compliance with industry regulations.
* Support the review and revision of technical documentation to align with current cGMP and regulatory standards.
* Assist in preparing equipment qualification documents (DQ)
* Maintain document control processes to ensure version accuracy and compliance.
* Proper stakeholder management to maintain a clear overview of all requirements, responsibilities and making sure you 'connected all the dots'
Requirements:
* 1-3 years of experience in technical writing, engineering, or process documentation within a pharmaceutical, biotech, or manufacturing environment.
* Bachelor's or Master's degree in Engineering, Life Sciences, Technical Writing, or a related field.
* Understanding of process equipment, P&ID interpretation, and pharmaceutical manufacturing processes.
* Familiarity with cGMP, FDA, and other industry regulations is a plus.
* Excellent written and verbal communication skills, with attention to detail.
* Ability to work collaboratively with cross-functional teams.