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Process Engineer II - Global MSAT Downstream jobs in United States
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Evotec · 4 hours ago

Process Engineer II - Global MSAT Downstream

Just-Evotec is a forward-thinking company that thrives on curiosity and innovation. They are seeking a passionate Process Engineer II to support downstream technology transfer and ensure that critical process parameters are validated for commercial manufacturing operations. The role involves collaboration with various teams and driving impactful projects while fostering personal and team growth.
BiotechnologyHealthcarePharmaceuticalHealth CareTherapeutics
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H1B Sponsor Likelynote

Responsibilities

Support downstream technology transfer of a late-stage molecule/commercial manufacturing and/or PPQ campaign support
Support site to site Tech Transfer activities
Support technology transfer activities ensuring gap analysis/risks assessments are performed and mitigation plans are in place and ensuring design spaces (PAR & NOR ranges) are built for critical process parameters for validation and support of late stage/commercial manufacturing operations
Support development, review and approval of technical documentation including global protocols for performance qualifications, batch records, and reports related to engineering, GMP and PPQ runs
Author templates for Process Validations and Continued Process Verification strategies
Conduct 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 for receiving sites across the Just MFG network

Qualification

Process EngineeringDownstream ProcessingTechnology TransferGMP ConceptsProcess Risk AssessmentData AnalysisInterpersonal SkillsCommunication SkillsOrganizational Skills

Required

Bachelor's degree in engineering, sciences, or related program with 2-5 years of relevant experience, or an MS degree
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 downstream processing including process chromatography and specifically continuous chromatography, large scale column packing, viral filtration, and tangential flow filtration 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 downstream 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

Preferred

Practical experience or knowledge downstream and disposable manufacturing technologies either at manufacturing scale or at bench-scale
Applies knowledge to solve complex technical problems
Technical resource for Downstream Manufacturing process and platform
Can work independently and in project teams; May lead projects within functional area expertise at Just Evotec
Ability to navigate global regulatory CMC documents
Experience with supporting late-stage manufacturing, Tech transfer and or Process Validation studies
Experience with DeltaV for process control

Benefits

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
Paid holiday
Wellness and transportation benefits

Company

Evotec is a pharmaceutical and life science company that provides drug discovery and gene therapy solutions.

H1B Sponsorship

Evotec has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (5)
2023 (2)
2022 (2)
2021 (3)
2020 (1)

Funding

Current Stage
Public Company
Total Funding
$746.74M
Key Investors
Bill & Melinda Gates FoundationKorea Advanced Institute of Science and TechnologyOpen Philanthropy
2025-05-07Grant· $2.5M
2025-01-22Grant
2023-12-19Grant· $2.5M

Leadership Team

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Christian Wojczewski
CEO
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Claudia Karnbach
EVP, Global Head of Partnerships and Alliances
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Company data provided by crunchbase