Technical Writer in Rockville

Job Description

Maxonic maintains a close and long-term relationship with our direct client. In support of their needs, we are looking for a

Technical Writer .

Job Title
Technical Writer

Job Type
Contract

Location
Rockville, MD

Work Schedule
On-site

Pay Rate
$31 per hour (based on experience)

Description
The Manufacturing Specialist is a key technical contributor responsible for process optimizations, manufacturing troubleshooting, and 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.

Conduct timely batch record reviews and deviation investigations, ensuring long-term resolution of documentation and 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 other 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 a relevant Science or Engineering discipline.

Minimum 3 years working within industry; strong technical writing capabilities are a plus.

Experience within cell/gene therapies, biologics, and/or cGMP regulated environment.

Knowledge of process improvement and lean methodologies.

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.

Equal Opportunity Statement
Maxonic is an equal opportunity employer. We welcome applications from all qualified individuals regardless of race, color, religion, gender, sexual orientation, national origin, age, disability, or veteran status.

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