Principal Process Engineer, MSAT

Job title: Principal Process Engineer

Location: Redmond WA

Reports to: Director Technical Operations

About Us:

At Just-Evotec Biologics we believe that curiosity is the spark that drives innovation and success. As a forward-thinking team we thrive on challenging the status quo learning from each other and pushing the boundaries of whats possible. Were on a mission to create a place where curiosity isnt just encouraged its celebrated.

Are you someone who asks questions seeks answers and isnt afraid to go deeper#BeCureious with us and see where your curiosity can take you!

The Role:

As a Principal Process Engineer on our Global MSAT Process Engineering team youll play a leading role in shaping the equipment technologies and single-use solutions used across the Just-Evotec Biologics manufacturing network.

What Youll Do:

• Lead the evaluation design development and implementation of new and existing manufacturing technologies across the Just-Evotec Biologics manufacturing network.

• Develop the lifecycle and maintenance management program for GMP equipment and technologies.
• Support the evaluation and approval of innovative technologies within the manufacturing platform through the project governance group.

• Work with key stakeholders and vendors to evaluate innovative technologies for implantation into the manufacturing process to increase efficiency and facility throughput.

• Work with cross functional teams on the development of global design documents (user requirement specifications software functional specifications) based on platform process requirements and validation commissioning and qualification protocols.

• Collaborate with Automation on the design and development of Distributed Control Systems (DCS) and integration of PLC-based equipment.

• Provide technical leadership for facility fit assessments utility requirements equipment layouts and associated Commissioning Qualification and Validation (CQV) activities.
• Evaluate and advance single-use technologies instrumentation manifolds and assemblies for use within the manufacturing platform.
• Work with vendors to test and develop equipment/technologies and develop the required data and validation packages to support these technologies in a GMP environment.

• Develop business processes guidelines SOPs (Standard Operating Procedures) and training for processing equipment and technologies.

• Build the equipment maintenance & life cycle plans to support the equipment deployed in the manufacturing network.

• Partner with Site MSAT Manufacturing Technology & Science teams on global and site objectives.

• Provide subject matter expert support in Non-Conformance investigation CAPAs and provide process impact evaluations of equipment issues.

Who You Are:

• BS in engineering sciences or related life science engineering 12 years of relevant experience in Pharmaceutical Biotech or Life Sciences industries or MS with 10 years of experience.

• Demonstrated technical expertise in biopharmaceutical manufacturing processes and technologies with strong knowledge of one or more areas such as chromatography filtration viral clearance drug substance formulation or upstream processing.

• Understanding of upstream cell culture expansion and processing operations including perfusion processing.

• Significant experience with single-use bioprocessing equipment technologies instrumentation and/or assemblies.

• Experienced in leading technology implementation and validation activities for clinical and commercial manufacturing readiness.

• Experience executing facility fit assessments and process validation activities.

• Demonstrated ability to work independently and lead collaborative cross-functional teams.

• Candidate must focus on quality attention to detail and effective task/time management organizational skills.

• Ability to organize analyze/interpret and present data and project updates to effectively information senior leadership.

Additional Preferred Qualifications:

• Experience with upstream processing including cell culture expansion and/or perfusion processing.

• Experience with DeltaV automation and the integration of PLC-based and non-PLC-based manufacturing equipment.
• Participation in global teams Center of Excellence etc.
• Applies knowledge and expertise to solve complex technical problems.

• Experience developing and executing CQV plans and protocols.

• Can work independently and in project teams; May lead cross functional projects at Just-Evotec utilizing functional area expertise.

Why Join Us:

• Growth Opportunities: Were a company that believes in continuous learning and development. Whether its professional courses mentorship or new projects well help you grow.
• Inclusive Culture: Were committed to building a diverse and inclusive environment where everyones voice is valued and curiosity is encouraged.
• Innovative Projects: Youll have the chance to work on groundbreaking initiatives and cutting-edge technology in an atmosphere where your curiosity is the key to success.
• A Place for Big Ideas: We dont just talk about thinking outside the box we throw the box away. If youve got ideas we want to hear them.

Are You Still Curious

If youve read this far then chances are youve got a curious mind just like us. So what are you waiting for Take the leap and apply today. We cant wait to see where your curiosity leads you and how it will shape the future of Just-Evotec.

Let your curiosity guide your career #BeCurious and explore the endless possibilities at Just-Evotec!

The base pay range for this position at commencement of employment is expected to be $134000 to $154100;Base salary offered may vary depending on individuals skills experience and competitive market value. Additional total rewards include discretionary annual bonus comprehensive benefits to include Medical Dental and Vision short-term and long-term disability company paid basic life insurance 401k company match flexible work generous paid time off and paid holiday wellness and transportation benefits.

Evotec (US) Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race gender age disability genetic information gender expression gender identity national origin religion sexual orientation or veteran status.