Manufacturing Engineer

The Manufacturing Technical Procedure Writer is responsible for creating, revising, and maintaining clear, accurate, and compliant standard operating procedures (SOPs), batch records, and other technical documentation for pharmaceutical manufacturing processes. This role ensures all documentation adheres to Good Manufacturing Practices (GMP), regulatory requirements (e.g., FDA, EMA), and internal quality standards. The ideal candidate is detail-oriented, has strong technical writing skills, and possesses a deep understanding of pharmaceutical manufacturing processes.

Key Responsibilities:

• Develop and Update Documentation: Write, edit, and maintain SOPs, batch records, work instructions, and other technical documents to support manufacturing operations, equipment use, and quality control processes.
• Ensure Regulatory Compliance: Ensure all documentation complies with GMP, FDA, EMA, and other relevant regulatory standards, as well as internal policies.
• Collaborate with Subject Matter Experts (SMEs): Work closely with manufacturing, quality assurance, validation, safety, and engineering teams to gather technical information and ensure accuracy and clarity in documentation.
• Streamline Processes: Translate complex technical processes into concise, user-friendly instructions to enhance operational efficiency and reduce errors.
• Document Control: Manage document lifecycle, including version control, reviews, approvals, and archiving, using electronic document management systems (EDMS).
• Training Support: Assist in developing training materials based on SOPs and provide support to ensure effective implementation of procedures.
• Continuous Improvement: Identify opportunities to improve documentation processes, readability, and usability, incorporating feedback from end-users.
• Audit Preparation: Support internal and external audits by ensuring documentation is accurate, up-to-date, and readily accessible.

Skills:

• Exceptional technical writing and editing skills with a focus on clarity, accuracy, and conciseness
• Strong understanding of pharmaceutical manufacturing processes, equipment, and terminology.
• Proficiency in document management systems (e.g., Veeva, Trackwise, MasterControl, Documentum) and Microsoft Office Suite.
• Ability to work collaboratively with cross-functional teams and manage multiple projects under tight deadlines.
• Knowledge of regulatory guidelines (e.g., 21 CFR Part 211, ICH Q7).
• Certifications (Preferred): Certification in Technical Writing (e.g., AMWA, STC) or GMP training.

Requirements

Qualifications:

• Education: Bachelor’s degree in Technical Writing, Pharmaceutical Sciences, Chemistry, Biology, Engineering, or a related field.
• Experience: 2+ years of technical writing experience in a pharmaceutical, biotechnology, or regulated manufacturing environment. Familiarity with GMP and regulatory requirements is highly preferred

Benefits

• Administrative shift
• 6-month contract with possible extension