Beschreibung

In this role, you will focus on validating mammalian manufacturing processes, ensuring compliance with regulatory standards, and collaborating with various teams. Your expertise will be vital in managing technical risks and enhancing process efficiency.

Anforderungen

• •Bachelor’s, Master’s or PhD degree in biotechnology, chemical engineering or related disciplines
• •Proven experience in managing complex projects
• •Minimum 1 year of experience in process validation within a cGMP-regulated biopharmaceutical environment
• •Working experience in biopharma manufacturing and/or process development preferable in Mammalian Manufacturing
• •Good understanding of GMP
• •Excellent communication, technical writing, and stakeholder management skills
• •Fluency in English

Aufgaben

• •Conduct process performance qualification activities
• •Execute continued process verification tasks
• •Plan, execute, and document validation protocols and reports
• •Align validation activities with regulatory expectations (FDA, EMA, ICH)
• •Manage technical risks associated with process validation
• •Ensure project completion aligns with project management goals
• •Collaborate with MSAT process experts and cross-functional teams
• •Communicate critical process and technical information effectively
• •Represent the company in customer meetings, audits, and inspections
• •Provide technical expertise during audits and inspections
• •Compile assessments of change requests and validation deviations
• •Review CMC sections in filing documents and validation reports
• •Participate in continuous improvement initiatives
• •Develop and implement standardized procedures for compliance
• •Share information and knowledge across teams and functions