Job Title: Process Engineer III, NPI – Site MSAT

Location: Seattle, WA

The Role:

We’re looking for a passionate and curious Process Engineer III to join our team. If you’re excited by new challenges, solving complex problems, and learning every step of the way, you might just be the perfect fit. In this role, you’ll have the opportunity to drive impactful projects, collaborate with bright minds, and explore uncharted territories.

This role is responsible for leading activities related to the introduction of new products to the J.POD Redmond and Seattle manufacturing facilities. The Process Engineer III, NPI will provide cross-functional leadership for all phases of Just-Evotec’s New Product Introduction (NPI) process – stretching from project initiation through to process validation and registration activities.

The Process Engineer III will require close collaboration with all functional areas of the J.POD Redmond & Seattle teams– including Product and Process Design, Process Engineering, Process Automation, Facilities Engineering, Validation, Quality Controls, Quality Assurance, Supply Chain, Manufacturing, Digital and EHS.  The role will participate in client facing meetings to discuss topics related to NPI activities. The role will also collaborate with Just-Evotec Global MSAT, Client Program Managers, Global Supply Chain for client projects and continuous improvement efforts.

What You'll Do:

• Lead stakeholders to implement the NPI process at J.POD Redmond and Seattle to support the start and rapid scale-up of commercial GMP manufacturing activities.
• Partner with Product and Process Design to coordinate successful efficient scale-up and transfer operations and to ensure the successful integration of process knowledge into manufacturing operations.
• Partner with supply chain to support Bill of Material development and demand planning for new products.
• Partner with Engineering and Digital disciplines to conduct facility fit assessments and plans to support system updates needed for new product introduction.
• Partner with Manufacturing to develop high-quality batch records, robust processes and innovative technology solutions for new product introduction.
• Partner with Quality, Validation and Global MSAT to develop and implement process validation and comparability study activities leading to successful product registration.
• Utilize the team’s technical skills and process knowledge to participate and/or lead investigations related to NPI activities. Collaborate with impacted groups to develop and execute effective CAPA.
• Apply Operational Excellence principles to lead continuous improvement in NPI activities.

Qualifications

• Masters (or Bachelors) degree in relevant field or related program with 3+ (5+) years of pharmaceutical/biotech experience
• Knowledge and experience with biologics drug substance tech transfer, including implementation of first-in-human and early stage clinical programs in manufacturing
• Knowledge and experience with late-stage clinical and commercial biologics drug substance manufacturing programs, including project leadership roles in process validation, PPQ commercial manufacturing.
• Proven record of accomplishment and self-directed leadership in GMP pharmaceutical or biotechnology is required.
• Knowledge and experience with cell culture, purification, and solution preparation operations using disposable-based manufacturing technologies
• Knowledge of US FDA CFRs and European EMA, including ICH guidelines, as they relate to drug substance biological manufacturing
• Good interpersonal, team, and collaborative skills are required.
• Excellent verbal and written communication skills and ability to interface with all levels of the organization

Additional Preferred Qualifications:

• Relevant experience (~2 years) of experience leading a New Product Introduction program for biopharmaceutical products.
• Experience in audits and inspections by health authorities, clients and other external auditors as a presenter or audit support staff.
• Demonstrated leadership capabilities to drive change, and influence internal and external stakeholders
• Experience in leading risk assessment and risk management for pharmaceutical products and processes. 
• Experience in applying principles of Quality by Design.
• Experience in developing submission packages for pharmaceutical product registration 
• Experience in client relations and communications.

Are You Still Curious?

If you’ve read this far, then chances are you’ve got a curious mind—just like us. So, what are you waiting for? Take the leap and apply today. We can’t 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 Evotec!

The base pay range for this position at commencement of employment is expected to be $92,400 to $126,500;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.

This job description is intended to describe the general content of the job, and to identify the essential functions of and requirements for the performance of this job.  It is not to be construed as an exhaustive statement of duties, responsibilities, or requirements. Because job requirements evolve with the changing needs of Just-Evotec Biologics business, this description is subject to change and may be modified at any time, whether formally or informally.