The selected candidate in the role of Process Engineer I as part of the GMSAT Technology team will support the design and development of new equipment and technologies for the Just-Evotec manufacturing network. The role will develop the support documentation for implantation of the technology and provide technical and operational support to 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 (including but are not limited to)
Support key stakeholders with the evaluation and implementation of existing and new processing technologies.
Work with project leads on design documents (user requirement specifications, software functional specifications) and validation commissioning and qualification protocols.
Evaluate single-use technologies and design single-use manifolds and assemblies
Work with vendors to develop data and validation packages supporting technologies.
Develop quotations for review and approval and work with procurement to submit POs
Develop business processes, guidelines, SOPs, and training for processing equipment and technologies
Support development equipment maintenance & life cycle plans
Partner with Site MSAT Manufacturing Technology & Science teams on global and site objectives
Position Requirements
BS in engineering, sciences, or related life science engineering 0-3 years of relevant experience in Pharmaceutical, Biotech, or Life Sciences industries
Working knowledge of cGMP manufacturing and regulatory regulations and requirements for biologics/pharmaceuticals
Solid understanding of monoclonal antibody processing either at manufacturing scale or in process development.
Demonstrated ability to work independently and collaboratively on cross-functional teams.
Working knowledge of manufacturing process equipment and automation systems
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, team, and collaborative skills are a must.
Excellent oral and written communication skills
Additional Preferred Qualifications:
Practical experience or knowledge of single-use disposable manufacturing systems
Experience using DeltaV automation
Participation in global teams, Center of Excellence, etc.
Applies knowledge and expertise to solve complex technical problems
Proficiency developing and executing commissioning/qualification (CQV) plans and protocols
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 $78,000 to $83,000; 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.
