Process Engineer III – Global MSAT |UPSTREAM

at  Evotec

Process Engineer III – Global MSAT |UPSTREAM
Just is seeking a highly motivated Process Engineer upstream in Global MSAT team that desires a significant opportunity to improve worldwide access to biotherapeutics.
The selected candidate as part of the Global MSAT Tech Transfer team supports Tech transfer leads with the implementation of network alignment strategy and creation of global templates/documentation for Tech transfer/New Product introduction across JUST Evotec. The primary focus of this job is to support site to site upstream tech transfer for late stage clinical and commercial biologics across the Global Manufacturing network. The staff member may also provide person-in-plant support, assist in generation of relevant regulatory submissions, provide support for regulatory and site inspections.

Responsibilities:

• Support upstream 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 late phase/ commercial programs for receiving sites across the Just MFG network.

Position Requirements: Bachelor’s degree in engineering, sciences, or related program with 5 + years of relevant experience, 2+ years of experience with an MS degree
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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 global regulatory CMC documents.
• Experience with supporting late-stage manufacturing, Tech transfer and or Process Validation studies.
• Experience with DeltaV for process control

The base pay range for this position at commencement of employment is expected to be
$95,650 to $126,000 ; 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, 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.

• Support upstream 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 late phase/ commercial programs for receiving sites across the Just MFG network