Process Engineer II – Downstream

Responsibilities

• Represents site MSAT on project teams as technical subject matter expert (SME)
• Develops process understanding and expertise
• Authors, reviews and owns process related documentation (technical documents, test protocols, batch records, process descriptions, SOPs, etc)
• Authors, reviews change controls including managing change implementation
• Utilizes technical skills and process knowledge to participate and/or lead investigations related to process/New product implementation
• Collaborates with impacted groups to drive implementation of CAPAs from approval to closure & effectiveness check
• Monitors and reports on process performance data analysis
• Shares 24/7 on call support activities during production
• Applies Operational Excellence principles to lead continuous improvement for downstream process improvements

• Masters (or Bachelors) degree in Engineering
• 2+ (5+) years of pharmaceutical/biotech experience
• minimum of 2-4 years of supporting downstream purification activities for biopharmaceutical products
• Proven record of accomplishment and self-directed leadership in GMP pharmaceutical or biotechnology
• Technical purification and solution preparation operations using disposable-based manufacturing technologies
• Demonstrated capabilities to work with high-performing teams
• Ability to drive change and influence internal and external stakeholders
• Good interpersonal, team, and collaborative skills
• Excellent verbal and written communication skills in English
• Experience in leading risk assessment and risk management for pharmaceutical products and processes
• Experience in applying principles of Quality by Design.