ClinLab Solutions Group is hiring: Technical Writer in Newtown

Technical Writer – Newtown, PA

The Technical Writer will support oral solid dosage pharmaceutical manufacturing by authoring, revising, and maintaining high-quality technical documentation in compliance with cGMP and FDA requirements. This role partners closely with Technical Services, Manufacturing, Quality Assurance, Validation, and Engineering to ensure controlled documents are accurate, clear, consistent, and inspection ready. The ideal candidate will demonstrate strong technical writing skills, attention to detail, and experience working within a regulated pharmaceutical manufacturing environment.

• This position’s responsibilities will include, but not be limited to the following:Author, review, and maintain controlled technical documents, including Standard Operating Procedures (SOPs), Master Production Records (MPRs), Master Packaging Records (MPKs), protocols, and technical reports.
• Prepare and revise documentation associated with technical changes, including change controls, risk assessments, and supporting justifications, in collaboration with cross-functional stakeholders.
• Support deviation, investigation, and CAPA documentation by drafting clear, factual, and technically accurate narratives and supporting documentation.
• Collaborate with subject matter experts across Technical Services, Manufacturing, Quality Assurance, Validation, and Engineering to translate complex processes into clear, compliant documentation.
• Ensure all technical documentation complies with cGMP requirements, FDA regulations, and internal document control standards.
• Participate in document lifecycle activities, including periodic review, version control, and archival, to maintain accuracy, consistency, and inspection readiness.
• We are looking for applicants with:Bachelor’s degree from an accredited college or university in a scientific, technical, or related discipline (e.g., Chemistry, Pharmaceutical Sciences, Biology, Engineering, or Technical Communication) required.
• Minimum of 1–5 years of experience authoring and managing technical documentation within a regulated pharmaceutical manufacturing environment.
• Experience supporting oral solid dosage manufacturing documentation strongly preferred.
• Solid understanding of cGMP principles and regulated documentation practices.
• Strong technical writing skills, including grammar, structure, clarity, and attention to detail.
• Ability to interpret technical information and collaborate effectively with subject matter experts.
• Proficiency with standard office software and document management systems used in regulated environments.
• Strong organizational skills and ability to manage multiple documents, priorities, and deadlines.
• Effective written and verbal communication skills and willingness to learn manufacturing processes and regulatory expectations.