Job Title: Technical Writer / Documentation Specialist
Location:
Duration: 6 Months contract (possible extension)
Shift: Mon - Fri
Position Summary:
The Manufacturing Specialist is a key technical contributor responsible for process optimizations, manufacturing troubleshooting, continuous improvement initiatives to ensure Manufacturing consistently produces quality product.
This role sits at the intersection of operational excellence, quality, training & development, and MSAT supporting efficient, compliant, and ever improving operations.
The ideal candidate will have a strong understanding of cGMP compliance, quality event investigation, lean production methodologies, and process technology to drive reliability in operations.
Key Responsibilities and Duties:- Process Improvement & Optimization
Identify and implement continuous improvement projects using Lean methodologies to improve and stabilize yield, efficiency, and process success.
Partner with MS&T and Process Development to monitor process performance to identify data-driven solutions and enhancements.
Support technology transfer, process scale-up, and process validation to ensure smooth transitions into manufacturing.
Partner with MS&T and Engineering to optimize equipment utilization, automation strategies, and data analytics for real time adjustments and support.
Compliance & Manufacturing Support
Conduct timely batch record reviews and deviation investigations, ensuring long term resolution of documentation/instructional issues.
Lead root cause analysis and corrective/preventive action (CAPA) for process deviations, non-conformances, and quality issues.
Work close with Quality and Manufacturing teams to ensure documentation supports data integrity & good documentation practices (GDP) incompliance with FDA, EMA, guidelines.
Training and Documentation Management
Develop and maintain SOPs, training materials, and documentation systems for manufacturing compliance and process improvements.
Partner with MS&T and Training to conduct training programs for manufacturing staff to ensure adherence to cGMP, process guidelines, and quality requirements.
Work cross-functionally to ensure employees remain qualified and up to date on process and compliance expectations.
Qualifications:
Bachelor’s degree in relevant Science or Engineering discipline preferred.
Minimum 3 years working within industry.
Strong technical writing capabilities a plus.
Experience within cell/gene therapies, biologics, and/or cGMP regulated environment preferred.
Knowledge of process improvement and lean methodologies preferred.
Ability to interpret and present complex scientific data in a clear and concise manner.
Proficient in Microsoft office suite and document management systems.
Strong organizational and project management skills.