Deviation Writer

Job Title: Deviation Writer

Job Overview:

Our organization, a leader in contract development and manufacturing for pharmaceuticals and biologics, is seeking a highly motivated and detail-oriented Deviation Writer to join our Manufacturing Engineering team. This critical role focuses on investigating and documenting deviations, non-conformances, and other technical events to ensure robust root cause analysis, effective corrective actions, and comprehensive preventive measures. The Deviation Writer will collaborate with cross-functional teams, including Manufacturing, Production Engineering, Quality, and Supply Chain, to produce clear, accurate, and compliant documentation. 

Job Responsibilities:

• Investigate and document a variety of deviations and non-conforming events across technical departments, working closely with Subject Matter Experts to ensure accuracy.
• Gather facts, analyze data, and utilize expertise to support robust root cause identification and investigation conclusions.
• Apply analytical tools such as Ishikawa Fishbone, 5 Whys, or similar methodologies to identify root causes of deviations.
• Develop and implement corrective and preventive actions, leveraging automation and engineering controls to enhance process reliability and error-proof systems.
• Translate complex technical processes and events into clear, concise, and understandable written reports.
• Collaborate with internal teams and external stakeholders to ensure investigations are comprehensive, logical, and well-documented.
• Review historical deviations, adverse events, and non-conformances to identify trends and recommend preventive measures.
• Utilize electronic Quality Management Systems (eQMS) and documentation tools to maintain accurate and compliant records.
• Support cross-functional initiatives to drive continuous improvement in manufacturing processes and documentation practices.

Qualifications:

• Bachelor’s degree in a scientific, engineering, or technical discipline required.
• Minimum of 3 years of experience in technical writing within a regulated GMP environment, preferably in pharmaceutical, biopharmaceutical, or biotechnology industries.
• Strong proficiency in writing clear, concise, and accurate technical documentation.
• In-depth understanding of GMP manufacturing processes and regulatory requirements.
• Familiarity with electronic document management systems (EDMS) and industry-standard documentation tools.
• Exceptional analytical and critical-thinking skills, with the ability to conduct thorough root cause analyses.
• Strong interpersonal and communication skills to foster productive collaboration with internal and external stakeholders.