Bioprocess Engineer

4 days ago


Rockville, Maryland, United States GlaxoSmithKline Full time
Job Summary

We are seeking a highly skilled Bioprocess Engineer to join our team at GlaxoSmithKline. As a Bioprocess Engineer, you will play a critical role in driving manufacturing improvement projects and providing technical expertise to support the development and implementation of new processes.

Key Responsibilities
  • Manufacturing Improvement: Develop and implement process improvements to increase efficiency, reduce costs, and enhance product quality.
  • Technical Expertise: Provide technical guidance and support to cross-functional teams to ensure the development and implementation of new processes meet regulatory requirements and company standards.
  • Process Development: Collaborate with process development teams to design, develop, and implement new processes and technologies to support the manufacturing of biologics and vaccines.
  • Technical Documentation: Develop and maintain technical documentation, including technical transfer documentation, technical risk assessments, and control strategies.
  • Quality Management: Ensure compliance with cGMPs and regulatory requirements by performing quality record management, initiating and resolving issues, and owning and managing process-specific change controls and CAPAs.
  • Training and Development: Develop and deliver training programs to manufacturing staff on new processes and technologies.
  • Project Management: Manage projects from concept to completion, working cross-functionally and providing adequate training to impacted areas.
Requirements
  • Education: Bachelor's degree in Engineering or related field (i.e., biotechnology, science, etc.).
  • Experience: 2+ years of biotech/life science/process development/pharmaceutical biologics GMP manufacturing-related experience.
  • Skills: Strong technical skills, excellent written and verbal communication skills, and ability to work independently and collaboratively in a fast-paced environment.
Preferred Qualifications
  • Facilitation and Demonstration Skills: Ability to facilitate and demonstrate complex concepts to technical and non-technical audiences.
  • Independent Collaboration: Ability to work independently and collaboratively with outside resources.
  • Business Software and Industry Systems: Proficiency with business software (i.e., Excel, Visio) and industry systems (ERP, Veeva).
  • Quality and Regulatory GMP Requirements: Knowledge of quality and regulatory GMP requirements in a biologics pharma/biotech industry.
  • cGMPs: Knowledge, understanding, and application of cGMPs as it relates to commercial operations.

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