Process Engineer III, – Global MSAT Process Validation, Based in Redmond, WA
Just is seeking a highly motivated Process Engineer III in Global MSAT team that desires a significant opportunity to improve worldwide access to biotherapeutics. The focus areas for this role are to provide project support of process validation and tech transfer activities for late-stage programs into PPQ / commercial biologics manufacturing. The selected candidate as part of the Global MSAT Tech Transfer and Process Validation functional area is responsible for supporting the creation of global documentation for Process Validation across JUST Evotec Manufacturing network. The team member will also provide in-plant support for execution of process validation and performance qualification runs, assist in the generation of relevant process validation protocols and reports, and provide support for regulatory and site inspections.
Responsibilities:
Support the authoring, review and approval of technical documentation including global protocols and templates for Process Performance Qualification runs and Process Validation studies.
Execute project-specific deliverables including but not limited to PPQ protocols and supporting validation such as mixing, hold time studies, impurity clearance, extractables & leachables and filter validation.
Support technology transfer activities ensuring process gap analysis/risks assessments are performed.
Support the analysis of process data including annual periodic reviews across the network of Manufacturing sites.
Author Process transfer document and or Process Control strategy for phase III and commercial programs across the Just MFG network.
Support site to site Tech Transfer and Process validation activities.
Position Requirements:
Bachelor’s degree in engineering science or related program with 5+ years relevant experience. 2+ years of experience with an MS degree.
Experience in supporting the execution of Process Validation activities for late-stage clinical manufacturing, PPQ campaigns / commercial campaign support.
Understanding industry standards and best practices for a science and risk-based approach to Process Validation.
Solid understanding of either upstream or downstream unit operations including perfusion cell cultures, chromatography, large scale column packing, viral filtration, and tangential flow filtration either at Manufacturing scale or in process development of biologics.
Understanding of GMP concepts and Quality systems necessary to execute process validation activities.
General knowledge of statistical analysis.
Strategic mindset, ability to organize, analyze/interpret, and effectively translate process validation expertise into global procedures/templates.
Working knowledge of US FDA CFRs and European EMA, including ICH regulations .
Good interpersonal, team, and collaborative skills.
Excellent oral and written communication skills.
Proven knowledge of cGMP requirements and experience writing manufacturing technical documents.
Experience executing technical projects and managing timelines with external collaborators and vendors.
Candidate must possess a strong focus on quality and attention to detail as well as effective task/ time management organizational skills.
Additional Preferred Qualifications:
Working knowledge of manufacturing process equipment, DeltaV automation systems, and Manufacturing Execution Systems.
Knowledge and expertise to solve complex technical problems; may apply novel approach that provides significant technology advancement.
Applies knowledge to solve complex technical problems.
Can work independently and in project teams; May lead projects within functional area expertise at Just Evotec.
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.
The base pay range for this position at commencement of employment is expected to be $110,000 to $126,500; Base salary offered may vary depending on the 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.
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What We Do
Evotec is a biotechnology company that is committed to advancing drug discovery and development. Through flexible business models, we collaborate with pharmaceutical companies, biotechs, foundations, and government agencies on a substantial scale. We believe that by working together, we can make a difference in the lives of patients.
Our Pipeline Co-Creation model represents our adaptable, multi-modality, fully integrated end-to-end approach to drive collaborations and services across all phases of drug discovery and development – from discovery of novel targets to achieving Proof of Concept in the clinic and into commercial manufacturing.
We aspire to contribute data-driven disease understanding and early disease relevance in humans to bring the probability of success up. We select the right modality, which is then propelled forward on our platforms by our passionate people striving for the fastest and most effective ways towards patient impact. This is enabled by convergence of human ingenuity with data and AI.
We also offer specific solutions, products, and CRO/CDMO-like services, always in support of the Biopharma R&D innovator. Our more than 4,000 scientists work closely with numerous partners concurrently, delivering fully integrated research and development portfolios or individual projects with the highest quality standards and efficiency, coupled with great science, passion, engagement, and communication.
