Technical Writer

The Fountain Group is currently seeking a Technical Writer for a prominent client of ours. This position is located in Rockville, MD.

Location:

Rockville, MD (100% Onsite)
Pay: $32/hr W2

Contract:

6-months (high possibility for extension based on performance and budget)

• 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.

• Bachelor's degree in a relevant science or engineering discipline preferred.
• Minimum 3 years working within industry. Strong technical writing capabilities a plus.
• Experience with in cell/gene therapies, biologics, and/or a 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.

• 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 and 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.

• 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 closely with Quality and Manufacturing teams to ensure documentation supports data integrity and good documentation practices (GDP) in compliance with FDA, EMA, and guidelines.

• 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.