Technical Writer / Manufacturing Specialist in Rockville

We are seeking a Technical Writer / Manufacturing Specialist to support manufacturing operations, process optimization, and continuous improvement initiatives in a cGMP-regulated environment. This role will focus on technical documentation, manufacturing support, compliance, process improvements, and training to ensure efficient, compliant, and high-quality manufacturing operations., Process Improvement & Manufacturing Support

• Identify and implement continuous improvement initiatives using Lean methodologies to improve manufacturing efficiency, yield, and process reliability.
• Collaborate with Manufacturing Science & Technology (MS&T) and Process Development teams to monitor process performance and recommend data-driven improvements.
• Support technology transfer, process scale-up, and process validation activities.
• Partner with Engineering and MS&T to optimize equipment utilization, automation strategies, and manufacturing processes.

Compliance & Quality

• Review batch records and support deviation investigations.
• Lead root cause analysis and implement Corrective and Preventive Actions (CAPA) for process deviations, non-conformances, and quality issues.
• Collaborate with Quality and Manufacturing teams to ensure documentation complies with cGMP, FDA, EMA, and Good Documentation Practices (GDP).
• Support data integrity and manufacturing compliance initiatives.

Technical Writing & Documentation

• Develop, revise, and maintain Standard Operating Procedures (SOPs), work instructions, training materials, and manufacturing documentation.
• Maintain documentation systems to support manufacturing compliance and process improvements.
• Ensure technical documents are accurate, compliant, and up to date.

Training & Cross-Functional Collaboration

• Partner with Training and MS&T teams to develop and deliver manufacturing training programs.
• Ensure employees remain qualified and compliant with manufacturing procedures and quality standards.
• Collaborate with cross-functional teams to support operational excellence and continuous improvement initiatives.

• Bachelor's degree in a Science, Engineering, or related discipline .
• Minimum 3 years of industry experience in a manufacturing or regulated environment.
• Strong technical writing and documentation skills.
• Experience in cell therapy, gene therapy, biologics, or other cGMP-regulated manufacturing environments is .
• Knowledge of Lean manufacturing and continuous improvement methodologies is .
• Ability to analyze and communicate complex scientific and technical information clearly.
• Proficiency with Microsoft Office Suite and document management systems.
• Strong organizational, analytical, and project management skills.
• Excellent written and verbal communication skills., * Experience supporting manufacturing operations in a regulated pharmaceutical, biotechnology, or life sciences environment.
• Familiarity with FDA, EMA, cGMP, CAPA, and Good Documentation Practices (GDP).
• Experience with process optimization, technology transfer, and manufacturing investigations.