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    Principal Process Engineer, Upstream - Redmond, United States - Evotec

    Evotec
    Evotec Redmond, United States

    1 week ago

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    Description
    Principal Process Engineer, Upstream
    • Manufacturing Technical OperationsJust-Evotec Biologics is seeking a motivated and creative Process Engineer that desires a significant opportunity to improve worldwide access to biotherapeutics.
    The selected candidate in the role of Principal Process Engineer as part of the GMSAT Technology team will lead the team responsible for the design and development of new equipment and technologies for the Just-Evotec upstream manufacturing network.

    The role will lead cross functional evaluations of technologies to improve and optimize upstream cell culture manufacturing, 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.


    Responsibilities:


    Develop strategies for the design and development of new and existing technologies across the Just-Evotec Biological Manufactuing networkSupport the evaluation and approval of innovative technologies within the manufacturing platform through the project governance groupWork 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 technologiesBuild 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 objectivesProvide subject matter expert support in Non-Conformance investigation, CAPAs and provide process impact evaluations of equipment issuesParticipate in internal and external audits/inspectionsRequirements:

    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 cell expansion, bioreactor design and operation and perfusion system design and operation.

    Understanding of downstream capture and clarification of cell culture harvest stream to drug substance.
    Experience working with single-use instrumentation and assemblies within a GMP manufacturing facility.

    Experienced in leading technology implementation and validation activities for clinical and commercial manufacturing readinessUnderstanding of GMP concepts and quality systems necessary to execute facility fit and process validation activities.

    Demonstrated ability to work independently and collaboratively on cross-functional teams.
    Candidate must focus on quality, attention to detail, and effective task/time management organizational skills.
    Ability to organize, analyze/interpret, and effectively communicate process data.
    Good interpersonal, leadership, team, and collaborative skills.

    Excellent oral and written communication skillsAdditional 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.

    The base pay range for this position at commencement of employment is expected to be $93,800 to $150,000; 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 and 401k company match, flexible 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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