Job Description

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.