Process Engineer 2
4 weeks ago
Just is seeking a highly motivated Process Engineer for the Site MSAT team that desires a significant opportunity to improve worldwide access to
biotherapeutics.
The role report to NPI Lead for site MSAT and will be responsible to support all aspects of upstream and downstream processing for multiple clinical-scale cGMP manufacturing trains employing the innovative Just-Evotec continuous processing platform in 24/7 operations.
Responsibilities:
Represents site MSAT on project teams as technical subject matter expert (SME) and interface with global MSAT, Operations and Quality functions.
Develop process understanding and expertise.
Authors, reviews and owns process related documentation (technical documents, test protocols, batch records, process descriptions, SOPs, etc)
Authors, reviews change controls including managing change implementation of the change as the assigned change agent.
Utilize technical skills and process knowledge to participate and/or lead investigations related to process/ New product implementation. Collaborate with impacted groups to drive implementation of CAPAs from approval to closure & effectiveness check.
Monitors and reports on process performance data analysis.
Ability to share 24/7 on call support activities during production.
Apply Operational Excellence principles to lead continuous improvement for upstream and downstream process improvements.
Position Requirements:
Bachelors degree in engineering with 2-5 years of relevant experience, or a masters degree in engineering with greater than 6 Months
Experience supporting process transfer / technology transfer projects and teams in the biopharmaceutical industry; commercial manufacturing campaign support is a plus.
Familiar with process risk assessment tools (e.g., FMEA) developing process models, and process trending.
Solid understanding of upstream processing including single-use bioreactor operations and perfusion technology either at Manufacturing scale or in process development of biologics.
Solid understanding of GMP concepts and quality systems necessary to support Tech Transfer and process validation activities.
Hands on experience of upstream disposable-based manufacturing technologies from bench-scale through commercial scale
Working knowledge of manufacturing process equipment and automation systems
Candidate must possess strong focus on quality and attention to detail as well as effective task/ time management organizational skills.
Ability to organize, analyze/interpret, and effectively communicate process data.
Good interpersonal, team, and collaborative skills are a must.
Excellent oral and written communication skills
Additional Preferred Qualifications:
Practical experience or knowledge of cell culture and upstream disposable manufacturing technologies either in Manufacturing or at bench-scale.
Applies knowledge to solve complex technical problems.
Technical resource for Upstream Manufacturing process and platform.
Can work independently and in project teams; May lead projects within functional area expertise at Just Evotec.
Ability to navigate regulatory CMC documents.
Experience with supporting late-stage manufacturing, Tech transfer and or Process Validation studies.
Experience with DeltaV for process control
About Just – Evotec Biologics
Just – Evotec Biologics, wholly-owned by Evotec SE, is a unique platform company that integrates the design, engineering, development, and manufacture of biologics. With deep experience in the fields of protein, process and manufacturing sciences, the Just team came together to solve the scientific and technical hurdles that block access to life-changing protein therapeutics; from the design of therapeutic molecules to the design of the manufacturing plants used to produce them. Just’s focus is to create access and value for a global market through scientific and technological innovation. Our state-of-the-art labs and cGMP clinical manufacturing plant are co-located in Seattle’s South Lake Union neighborhood – the center of Seattle’s medical, global health, and technology industries and a noted top emerging life science hub in the U.S. Our fast-growing team of 200+ employees is expanding Just’s innovative platform and footprint – building our first North American J.POD commercial manufacturing facility in the Seattle area. For job opportunities, learn more at
www.just.bio/careers
The base pay range for this position at commencement of employment is expected to be $
68,000 to $86,250.
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.
Evotec is a life science company with a unique business model that delivers on its mission to discover and develop highly effective therapeutics and make them available to the patients. The Company’s multimodality platform comprises a unique combination of innovative technologies, data and science for the discovery, development, and production of first-in-class and best-in-class pharmaceutical products. Evotec leverages this “Data-driven R&D Autobahn to Cures” for proprietary projects and within a network of partners including all Top 20 Pharma and over 800 biotechnology companies, academic institutions, as well as other healthcare stakeholders. Evotec has strategic activities in a broad range of currently underserved therapeutic areas, including e.g. neurology, oncology, as well as metabolic and infectious diseases. Within these areas of expertise, Evotec aims to create the world-leading co-owned pipeline for innovative therapeutics and has to-date established a portfolio of more than 200 proprietary and co-owned R&D projects from early discovery to clinical development. Evotec operates globally with more than 5,000 highly qualified people. The Company’s 17 sites offer highly synergistic technologies and services and operate as complementary clusters of excellence. For additional information please go to www.evotec.com
and follow us on X/Twitter @Evotec
and LinkedIn .
Please click on the link below to access and review our Privacy Information for Applicants:
#J-18808-Ljbffr
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