Process Engineer II - Downstream - Site based Redmond WA
Process Engineer II - Downstream - Site based Redmond WA
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Job Description
JustEvotec Biologics is seeking a highly motivated Downstream Process Engineer II for site MSAT to join a fastpaced collaborative and multidisciplinary team. The role report to Downstream Lead for site MSAT and will be responsible to support all aspects of downstream processing for multiple clinicalscale cGMP manufacturing trains employing the innovative JustEvotec continuous processing platform in 24/7 operations.
Roles and responsibilities:
- Represents site MSAT on project teams as technical subject matter expert (SME) and interface with global MSAT Operations and Quality functions.
- Develop process understanding and expertise.
- Authors reviews and owns process related documentation (technical documents test protocols batch records process descriptions SOPs etc)
- Authors reviews change controls including managing change implementation of the change as the assigned change agent.
- Utilize technical skills and process knowledge to participate and/or lead investigations related to process/ New product implementation. Collaborate with impacted groups to drive implementation of CAPAs from approval to closure & effectiveness check.
- Monitors and reports on process performance data analysis.
- Ability to share 24/7 on call support activities during production.
- Apply Operational Excellence principles to lead continuous improvement for downstream process improvements.
Position Requirements:
- Masters (or Bachelors) degree in Engineering with 2 5 years of pharmaceutical/biotech experience including a minimum of 24 years of supporting downstream purification activities for biopharmaceutical products.
- Proven record of accomplishment and selfdirected leadership in GMP pharmaceutical or biotechnology is required.
- Technical purification and solution preparation operations using disposablebased manufacturing technologies.
- Demonstrated capabilities to work with highperforming teams drive change and influence internal and external stakeholders.
- Good interpersonal team and collaborative skills are required.
- Excellent verbal and written communication skills in English; ability to interface with all levels of the organization.
- Experience in leading risk assessment and risk management for pharmaceutical products and processes. Experience in applying principles of Quality by Design.
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 $80000 to $86250; 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
