Beschreibung

In this role, you will focus on ensuring the successful validation of mammalian manufacturing processes. You will collaborate with various teams to manage technical risks and maintain compliance while actively participating in audits and continuous improvement initiatives.

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 process validation deviations
• •Review CMC sections in filing documents and validation reports
• •Participate in continuous improvement initiatives
• •Develop validation lifecycle strategies
• •Implement standardized procedures for compliance across the network
• •Share knowledge and information across teams and functions