Specialist, Production Project Support

Essential Duties & Key Responsibilities

• Assist in the identification, documentation, and implementation of business process improvements to enhance efficiency, quality, and cost-effectiveness.
• Coordinate data collection and analysis to support root cause investigations and improvement initiatives.
• Support the preparation, tracking, and execution of change control documentation in compliance with quality and regulatory standards.
• Ensure all impacted stakeholders are involved in the review and approval of changes.
• Maintain accurate records of change implementation and outcomes.
• Support the execution and documentation of corrective and preventive actions, including follow-up activities.
• Assist in CAPA investigations by compiling data, organizing cross-functional meetings, and tracking completion of action items.
• Ensure CAPA documentation meets internal and regulatory expectations.
• Draft, revise, and maintain SOPs in collaboration with subject matter experts.
• Ensure SOPs reflect current best practices and regulatory requirements.
• Facilitate training rollout and ensure personnel are informed of updated procedures.
• Track progress of ongoing production-related projects and report on milestones, issues, and risks.
• Schedule and facilitate cross-functional meetings as needed to support project deliverables.
• Maintain accurate and organized project documentation.

Minimum Qualifications

• Bachelor’s degree in Life Sciences, Engineering, or related field.
• 2+ years of experience in a GMP-regulated biotech or pharmaceutical environment.
• Project management knowledge is a plus.
• Technical writing skills a plus.
• Strong understanding of cell therapy, biotech or pharmaceutical manufacturing processes 
• Proven track record of successfully implementing improvement projects
• Knowledge of FDA, EMA, and global regulatory expectations for advanced therapy medicinal products is preferred.
• Excellent communication, leadership, and organizational skills.
• PMP Certification or equivalent formal project management training is preferred
• Familiarity with Lean Six Sigma or operational excellence methodologies is a plus

Travel Requirements and Work Environment

• Domestic and international travel not required. 
• On-site presence required, especially during critical project phases or production support.
• May involve gowning and working in classified cleanroom environments, including no jewelry, makeup, etc.
• Occasional off-hours or weekend work depending on project needs.