Just is seeking a highly-motivated Quality Engineer within the Quality Systems group that desires to be part of a team focused on improving worldwide access to Biotherapeutics! The role’s primary responsibility is to build and deploy a robust quality risk management (QRM) program throughout the GMP space at Just-Evotec Biologics. Additionally, the candidate will also have to opportunity to support other Quality Engineers within the team and provide technical and quality oversight of equipment qualification and validation activities. This role will build, provide guidance, and implement proactive risk management to support, justify, and defend GMP policies and procedures at Just-Evotec Biologics.
- Lead a cross-functional team to develop and implement a proactive risk management program for GMP operations at Just-Evotec Biologics.
- Develop processes and trainings for systems to support the risk management program.
- Develop and implement processes/methodologies to maintain consistency across risk assessments.
- Build and lead a risk management committee to provide oversight and decisions regarding risk profile.
- Create a site risk register tool for prioritizing risk mitigation.
- Develop compliant novel ways to comply with regulatory requirements around risk management.
- Develop and improve the Quality Risk Management program, including facilitating data-driven risk assessments and risk reviews, by combining technical and compliance-based rationale to drive procedures.
- Apply extensive knowledge of technical & validation (PQS) standards/requirements and industry guidance to influence the interpretation of governing requirements as it relates to Quality Systems & Validation.
- Implement and maintain the PQS as it pertains to systems validation for Just.
- Provide Quality oversight to quality risk management documentation and equipment facilities utilities qualification for a process transfer from development to commercial drug substance manufacturing.
- Mentor manufacturing and development groups in qualification/validation technical aspects, and compliance requirements.
- Provide Quality guidance, strategy, and presentation of topics during external audits.
- Works collaboratively with both internal/external collaborators, vendors, and regulatory agencies to anticipate and resolve quality issues as well as maintain GMP compliance.
Qualifications and Educational Requirements
The right candidate will possess the following skills and experience.
- Bachelor’s degree in biological sciences, chemistry, biochemistry, engineering or related life science field.
- 8 – 10+ years relevant experience in a biopharmaceutical cGMP manufacturing or similar environment.
- Experience authoring, reviewing, and approving risk assessments.
- Sound knowledge of cGMPs and guidelines set forth in ICH Q8, 9, 10 and ISPE Commissioning and Qualification Baseline Guide.
- Solid technical understanding of GMP biologics manufacturing processes and equipment.
- The ability to work both independently and collaboratively with scientific and engineering staff across multiple disciplines in a fast-paced and dynamic environment.
- Involvement with both technical and quality aspects of biologics manufacturing.
- Knowledge and expertise to solve complex technical problems.
- Significant experience navigating and managing various modules in a Quality Management System software suite.
- Excellent verbal and written communication skills.
- Strong focus on quality and attention to detail.
- Possess effective task/time management organization skills
- Capacity to develop solutions to technical issues of moderate to complex scope.
About Just – Evotec Biologics
Just – Evotec Biologics, wholly-owned by Evotec SE, is a unique platform company that integrates the design, engineering, development, and manufacture of biologics. With deep experience in the fields of protein, process and manufacturing sciences, the Just team came together to solve the scientific and technical hurdles that block access to life-changing protein therapeutics; from the design of therapeutic molecules to the design of the manufacturing plants used to produce them. Just’s focus is to create access and value for a global market through scientific and technological innovation. Our state-of-the-art labs and cGMP clinical manufacturing plant are co-located in Seattle’s South Lake Union neighborhood – the center of Seattle’s medical, global health, and technology industries and a noted top emerging life science hub in the U.S. Our fast-growing team of 100 employees is expanding Just’s innovative platform and footprint – building our first North American J.POD® commercial manufacturing facility in the Seattle area. For job opportunities, learn more at www.just.bio/careers
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