Process Engineer I - Site based Redmond, WA
Process Engineer I - Site based Redmond, WA
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Job Description
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 JustEvotec 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 personinplant 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 singleuse technologies and design singleuse 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 03 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 crossfunctional 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 singleuse 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 JustEvotec 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 $78000 to $83000; Base salary offered may vary depending on the individuals skills experience and competitive market value. Additional total rewards include discretionary annual bonus comprehensive benefits to include Medical Dental and Vision shortterm and longterm 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.
Employment Type
Full-Time
