Process Engineer III Site Based, covering Redmond & Seattle, WA
Process Engineer III Site Based, covering Redmond & Seattle, WA
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Job Description
Job Title: Process Engineer III DownstreamSite MSAT
Location: Just Evotec Biologic. Redmond WA and Seattle WA - Covering both site.
Shifts: All days Monday to Friday with flexible as required weekend cover.
About Us: this is who we are
At Just Evotec Biologic we believe that curiosity is the spark that drives innovation and success. As a forward-thinking team we thrive on challenging the status quo learning from each other and pushing the boundaries of whats possible. Were on a mission to create a place where curiosity isnt just encouragedits celebrated.
Are you someone who asks questions seeks answers and isnt afraid to go deeper #BeCureious with us and see where your curiosity can take you!
The Role: / your challenge in our journey
Were looking for a passionate and curious Process Engineer III to join our team. If youre excited by new challenges solving complex problems and learning every step of the way you might just be the perfect this role youll have the opportunity to drive impactful projects collaborate with bright minds and explore uncharted territories.
As a Process Engineer III at Just Evotec Biologic youll have the freedom to ask the hard questions think outside the box and find creative solutions that push us forward. Its a role where your curiosity will fuel both your personal growth and the success of the team.
The Process Engineer III Downstream for Site MSAT is part of a fast-paced collaborative and multidisciplinary team. The role reports to Downstream Lead for site MSAT and is responsible to support all aspects of downstream processing for multiple clinical-scale cGMP manufacturing trains employing the innovative Just-Evotec continuous processing platform in 24/7 operations.
What Youll Do:
Promotes a culture of safety
Represents site MSAT on internal and external project teams as technical subject matter expert (SME) and interfaces with global MSAT Manufacturing Operations and Quality functions.
Possesses a deep understanding of downstream processes for the purification of biologics.
Authors reviews and approves process related documentation (technical documents test protocols batch records process descriptions SOPs)
Leads complicated and multi-disciplinary change controls and will function as a lead for the project team.
Partner with Quality Validation and Global MSAT to develop and implement process validation and comparability studies leading to successful product registration.
Is confident to act as a subject matter expert for regulatory and client inspection audits.
Utilize technical skills and process knowledge to participate and/or lead investigations related to process issues/deviation. Collaborate with impacted groups to drive implementation of CAPAs from approval to closure & effectiveness check.
Facilitates new product introduction by leading make-a-batch sessions and supporting technical training for manufacturing.
Skilled at organizing data to optimize analysis and trending
Experienced investigator and knowledgeable of root cause analysis tools (RCA)
Support and on-call rotating to support 24/7 operations
Apply Operational Excellence principles to lead continuous improvement ideas for downstream manufacturing.
Who You Are:
Masters (or Bachelors) degree in Engineering with 4 (7) years of pharmaceutical/biotech experience including a minimum of 2 years of supporting downstream purification activities for biopharmaceutical products.
Knowledge and experience CMC stage gates for clinical and commercial biologics drug substance manufacturing programs.
Proven record of accomplishment and self-directed leadership in GMP pharmaceutical or biotechnology is required.
Technical purification and solution preparation operations using disposable-based manufacturing technologies
Demonstrated capabilities to work with high-performing teams drive change and influence internal and external stakeholders
Extensive knowledge of US FDA CFRs and European EMA including ICH guidelines as they relate to drug substance biological manufacturing
Good interpersonal team and collaborative skills are required.
Additional Preferred Qualifications:
Experience in supporting audits and inspections by health authorities clients and other external auditors as a presenter or audit support staff.
Experience in leading risk assessment and risk management for pharmaceutical products and processes. Experience in applying principles of Quality by Design.
Entrepreneurial drive to achieve business objectives.
Why Join Us:
Growth Opportunities: Were a company that believes in continuous learning and development. Whether its professional courses mentorship or new projects well help you grow.
Flexible Work Environment: We offer flexible work options to help you balance your professional and personal life whether that means working remotely or choosing a hybrid model. Site based covering as required Seattle or Redmond WA.
Inclusive Culture: Were committed to building a diverse and inclusive environment where everyones voice is valued and curiosity is encouraged.
Innovative Projects: Youll have the chance to work on groundbreaking initiatives and cutting-edge technology in an atmosphere where your curiosity is the key to success.
A Place for Big Ideas: We dont just talk about thinking outside the boxwe throw the box away. If youve got ideas we want to hear them.
Are You Still Curious
If youve read this far then chances are youve got a curious mindjust like us. So what are you waiting for Take the leap and apply today. We cant wait to see where your curiosity leads youand how it will shape the future of Just Evotec Biologic.
Let your curiosity guide your career#BeCurious and explore the endless possibilities at Just Evotec Biologic!
The base pay range for this position at commencement of employment is expected to be $92400 to $126500; 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 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.
Employment Type
Full-Time
