Principal Process Engineer, MSAT

Evotec SE; Redmond (WA); In loco; USD 134.000 - 154.000; Tempo pieno

Descrizione del lavoro

Just-Evotec Biologics in Redmond, WA seeks a Principal Process Engineer to lead the design and development of new equipment and single-use technologies for the manufacturing network. The role drives cross-functional evaluations, prepares validation and regulatory documentation, and supports global processing platforms.

The successful candidate will guide global design documents, work with automation on DCS integration, and partner with Site MSAT Manufacturing Technology & Science teams to

Competenze

• BS in engineering, sciences, or related life science engineering with 12+ years of relevant experience.
• SME knowledge in cell culture biopharmaceutical manufacturing, chromatography, filtration operations, viral clearance, and drug substance formulation.
• Understanding of upstream cell culture expansion and processing operations, including perfusion processing.
• Experience designing and developing GMP single-use instrumentation and assemblies; knowledge of Leachable & Extractables programs.
• Experience leading technology implementation and validation activities for clinical and commercial manufacturing readiness.
• Experience executing facility fit assessments and process validation activities.
• Ability to work independently and lead cross-functional teams.
• Attention to quality, attention to detail, and effective task/time management.
• Ability to organize, analyze/interpret, and present data to senior leadership.

Mansioni

• Develop strategies for the design and development of new and existing technologies across the Just-Evotec Biological 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 the automation team on design and development of the Distribute Control System (DCS) with the manufacturing suite and integration of PLC based systems into the DCS.
• Support technical evaluations of the facility utility requirements, layouts within the manufacturing area and support associated CQV (Commissioning, Qualification, and Validation) activities.
• Evaluate single-use technologies for data acquisition and suitability within single-use manifolds and assemblies.
• 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.

Conoscenze

Cell culture biopharmaceuticals

Chromatography

Filtration operations

Viral clearance

Drug substance formulation design

Upstream cell culture processing

Single-use instrumentation design

Leachable & Extractables

GMP equipment

Technology implementation & validation

CQV/commissioning/qualification

Data analysis & presentation

Project leadership

Formazione

BS in engineering or life sciences

MS in engineering or life sciences

Descrizione del lavoro

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 what’s possible. We're on a mission to create a place where curiosity isn't just encouraged, it’s celebrated.

Are you someone who asks questions, seeks answers, and isn't afraid to go deeper? #BeCureious with us and see where your curiosity can take you!

The Role:

Just-Evotec Biologics is seeking a motivated and creative Process Engineer that desires a significant opportunity to improve worldwide access to biotherapeutics.

The selected candidate for the Principal Process Engineer role as part of the GMSAT Process Engineering team will lead the team responsible for the design and development of new equipment, technologies and single-use materials for the Just-Evotec Biologics manufacturing network. The role will lead cross functional evaluations of technologies to improve and optimize the biomanufacturing platform, develop the support documentation for implantation of the technology into our global processing platform and provide technical and operational support to Just-Evotec’s Site MSAT and Manufacturing Operations groups. The role may also provide person-in-plant support, assist in generation of relevant regulatory submissions, provide support for regulatory and site inspections.

What You'll Do:

• Develop strategies for the design and development of new and existing technologies across the Just-Evotec Biological 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 the automation team on design and development of the Distribute Control System (DCS) with the manufacturing suite and integration of PLC based systems into the DCS.

• Support technical evaluations of the facility utility requirements, layouts within the manufacturing area and support associated CQV (Commissioning, Qualification, and Validation) activities.

• Evaluate single-use technologies for data acquisition and suitability within single-use manifolds and assemblies.

• 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.

• Possess SME (Subject Matter Expert) knowledge in cell culture biopharmaceutical manufacturing, specifically around chromatography, filtration operations, viral clearance and drug substance formulation design and operations.

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

• Experience designing and developing GMP single-use instrumentation and assemblies with knowledge of Leachable & Extractables programs.

• 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 developing and providing oversight to continuous process monitoring and manufacturing strategies.

• Experience using DeltaV automation to control both PLC based and non-PLC based equipment.

• Participation in global teams, Center of Excellence, etc.

• Applies knowledge and expertise to solve complex technical problems.

• Proficiency in providing technical expertise in developing and executing commissioning/qualification (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: We’re a company that believes in continuous learning and development. Whether it’s professional courses, mentorship, or new projects, we’ll help you grow.
• Inclusive Culture: We’re committed to building a diverse and inclusive environment where everyone’s voice is valued, and curiosity is encouraged.
• Innovative Projects: You’ll 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 don’t just talk about thinking outside the box, we throw the box away. If you’ve got ideas, we want to hear them.

Are You Still Curious?

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 $134,000 to $154,100; Base salary offered may vary depending on individual’s 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.