Job Description

Technical Writer - Contract - Norton, MA

Proclinical is seeking a Manufacturing Technical Procedure Writer to create, revise, and maintain clear and compliant standard operating procedures (SOPs), batch records, and other technical documentation for pharmaceutical manufacturing processes. This role focuses on ensuring all documentation meets Good Manufacturing Practices (GMP) and regulatory requirements. You will be detail-oriented with strong technical writing skills and a solid understanding of pharmaceutical manufacturing processes.

The Technical Writer will:

• Write, edit, and maintain SOPs, batch records, work instructions, and other technical documents.
• Ensure documentation complies with GMP, FDA, EMA, and internal policies.
• Collaborate with manufacturing, quality assurance, validation, safety, and engineering teams.
• Translate complex technical processes into concise, user-friendly instructions.
• Manage document lifecycle using electronic document management systems (EDMS).
• Assist in developing training materials based on SOPs.
• Identify opportunities to improve documentation processes and usability.
• Support internal and external audits by maintaining accurate and accessible documentation.

Skills & Requirements:

• Bachelor's degree in Technical Writing, Pharmaceutical Sciences, Chemistry, Biology, Engineering, or related field.
• Proficiency in technical writing and editing with a focus on clarity and accuracy.
• Understanding of pharmaceutical manufacturing processes and terminology.
• Experience with document management systems and Microsoft Office Suite.
• Ability to collaborate with cross-functional teams and manage multiple projects.
• Knowledge of regulatory guidelines such as 21 CFR Part 211, ICH Q7.
• Certification in Technical Writing or GMP training is preferred.

If you are having difficulty in applying or if you have any questions, please contact Anderson Maldonado at [email protected]



Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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