Description
Join a team dedicated to advancing the manufacturing of drug substances that improve lives. As a Process Engineer, you will develop and optimize processes to make medicines safely and efficiently. You will collaborate closely with cross-functional partners who share a commitment to science, quality, and continuous improvement.
Responsibilities:
- Lead the design, specification, procurement, installation, commissioning, validation, and continued technical support of bioprocess equipment and facility design / operation
- Facilitate multi-disciplined teams in the performance of HAZOPs, FMEAs, process reviews and SOP development efforts
- Act as a primary interface with outside engineering consulting firms on process design projects
- Manage vendors, consultants and contractors to ensure that process and project design and installation are in compliance with cGMP requirements & GSK Bio standards
- Stay current with technical developments in the field of vaccine formulation and manufacturing equipment design, equipment, control technology and GSK-Bio Standards
- Ensure all validation, quality, engineering, safety, and environmental procedures and regulations are met, maintained and documented appropriately
Basic Qualifications:
- Bachelor’s degree in engineering for a scientific field
- Minimum of 5 + years of experience in process engineering within pharmaceutical or medical device manufacturing
- Experience with Good Manufacturing Practices, Pharma or Vaccine formulation and filling facilities
- Technical understanding of the pharmaceutical industry and engineering practices
Preferred Qualifications:
- Demonstrated self-direct work habits along with verbal and written communication skills
- Familiarity with regulatory expectations regarding electronic records and electronic signatures
- Experience with process flow design and process optimization techniques
- Proven skills in documentation for compliance and regulatory audits