GMP Technical Writer

Merck KGaA Darmstadt Germany - Saint Louis, MO

Full-time - Mid Level

Saint Louis, MO

Chemical Manufacturing

About the position

The Technical Writer is responsible for the creation of batch records for use in GMP (Good Manufacturing Practice) manufacturing of new custom products. This role is crucial as it involves working cross-functionally at multiple manufacturing facilities, collaborating with various departments including Manufacturing, Process and Analytical Development, Quality, Project Management, and customers. The primary goal is to develop robust manufacturing batch records derived from Tech Transfer documents. The ideal candidate will possess strong composition skills and a comprehensive technical knowledge and understanding of manufacturing equipment and production processes. This position is based in St. Louis, Missouri, and requires a candidate who is detail-oriented and capable of conveying technical, safety, and GMP compliance information effectively through writing. In this role, the Technical Writer will engage with internal departments and customers to ensure that all documentation meets the necessary standards and requirements. The position demands a high level of attention to detail and the ability to communicate complex information clearly and concisely. The successful candidate will play a vital role in supporting the manufacturing process by ensuring that all batch records are accurate, comprehensive, and compliant with GMP regulations. This is an exciting opportunity for someone looking to contribute to innovative solutions in the healthcare and life sciences sectors.

Responsibilities

• Create batch records for GMP manufacturing of new custom products.
• Collaborate with Manufacturing, Process and Analytical Development, Quality, Project Management, and customers to develop manufacturing batch records.
• Ensure all documentation meets GMP compliance standards.
• Convey technical, safety, and GMP compliance information through writing.
• Communicate effectively with internal departments and customers.

Requirements

• Bachelor's degree in Biology, Chemistry, Biochemistry or another life science discipline.
• 2+ years' experience in GMP Operations, manufacturing or production operations.

Nice-to-haves

• 5+ years' experience in GMP Operations, manufacturing or production operations.
• 1+ years' experience writing GMP batch records.
• Excellent attention to detail in written instruction and communication.
• Strong composition skills to convey technical information effectively.
• Comprehensive technical knowledge of GMP manufacturing equipment and production processes.

Benefits

• Diversity and inclusion initiatives
• Opportunities for professional development and growth
• Supportive work culture that values innovation and collaboration