This company is a leading biotechnology firm dedicated to providing leading pharmaceutical products and is committed to maintaining the highest standards. The company has created a great culture that allows for growth, teamwork, and employment security. They are one of the world market leaders in their segment of the pharmaceutical marketplace.

As a Bioprocess Engineer specializing in Aseptic processing,  you will play a pivotal role in Sterility Assurance and Contamination Control, ensuring the integrity and quality of our manufacturing operations. By providing technical expertise and leadership, you will contribute to the development and implementation of robust Sterility Assurance strategies aligned with global standards, regulatory requirements, and industry best practices.

RESPONSIBILITIES

Collaborate with cross-functional teams to develop and implement Sterility Assurance and contamination control strategies including Process Validation, Aseptic Validation, Cleaning Validation and developing and owning the processes.

• Act as a subject matter expert in Sterility Assurance and microbiology, providing guidance and support to process teams.
• Lead the development and ownership of Contamination Control Strategies (CCS) and related procedures to ensure compliance with Good Manufacturing Practices (GMP) and regulatory expectations.
• Partner with internal stakeholders and suppliers to define validation/qualification requirements for facility, equipment, and processes.
• Conduct troubleshooting, risk assessments, and support regulatory inspections as needed.
• Oversee the execution of validation activities for product manufacturing, aseptic processing, and sterilization cycles.
• Drive corrective actions and root cause analyses to resolve deviations related to Sterility Assurance.

QUALIFICATIONS

• Bachelor's degree in engineering, microbiology/biology, or related field.
• 3+ years of experience in aseptic processing, parenteral, biological, or filling operations  including environmental monitoring and
• Proven experience in sterile manufacturing risk assessments and remediation implementation.
• Familiarity with applicable Global Regulatory, Quality and ISO standards such as FDA (Food and Drug Administration), EU (European Union) GMP, USDA (United States Department of Agriculture), and CFIA (Canadian Food Inspection Agency)
• Experience with upstream production of viruses in cell monolayers, bioreactors, or fermenters would be helpful.