Global MSAT Principal Process Engineer — Tech Transfer Lead

Evotec; Redmond; Presencial; AUD 222.000 - 246.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Growth opportunities

Flexible work options

Inclusive culture

Innovative projects

Big ideas culture

Descripción de la vacante

Just Evotec Biologics seeks a Principal Process Engineer to drive late-stage tech transfer for clinical and commercial biologics, leading cross-site efforts in the Global MSAT team. You will develop and maintain documentation, support regulatory submissions, and mentor junior engineers while advancing process control strategies.

You will oversee tech transfer activities, perform risk assessments, and contribute to process validation plans across multiple sites, ensuring GMP compliance and

Formación

• Bachelor's degree in engineering with 12+ years' experience (or MS with 8+ years of relevant experience).
• Subject matter expert in downstream processing (continuous chromatography, large-scale packing, viral filtration, tangential flow filtration).
• Subject matter expert in cell culture biopharmaceutical manufacturing and scale-up strategies.
• Experience leading technology transfer and process validation activities for late-stage clinical manufacturing and commercial campaigns.
• Understanding of GMP concepts and quality systems for process transfer and validation activities.
• Experience developing continuous process monitoring strategies and CPPV status throughout commercial lifecycle.
• Authoring regulatory CMC documents and coordinating responses to health authority questions.
• Strong background in statistics.
• Experience with process risk assessment tools (FMEA).
• Knowledge of DeltaV automation systems and MES.

Responsabilidades

• Lead technology transfer for late-stage molecule/PPQ campaigns.
• Coordinate site-to-site tech transfer activities across the network.
• Develop templates for process validations and continued process verification strategies.
• Lead analysis of process data across the network of manufacturing sites.
• Support regulatory submissions and inspections.

Conocimientos

Downstream processing

Cell culture

Tech transfer

Process validation

GMP compliance

Statistical analysis

Risk assessment

DeltaV automation

MES

Project leadership

Educación

Bachelor's degree in engineering

MS in engineering

Herramientas

DeltaV automation

MES

Descripción del empleo

Just Evotec Biologics seeks a Principal Process Engineer to drive late-stage tech transfer for clinical and commercial biologics, leading cross-site efforts in the Global MSAT team. You will develop and maintain documentation, support regulatory submissions, and mentor junior engineers while advancing process control strategies.

You will oversee tech transfer activities, perform risk assessments, and contribute to process validation plans across multiple sites, ensuring GMP compliance and