Just-Evotec Biologics 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 is responsible for providing technical and quality oversight of equipment qualification and validation activities, ensuring that the program and execution are fully compliant with the Just Pharmaceutical Quality System (PQS) and regulations. This role will build, provide guidance, and develop solutions to complex equipment qualification and validation efforts to enable the timely and compliant completion of Just’s new biologics manufacturing facility in Redmond, WA.
- Oversee and develop the qualification and validation programs at Just.
- Develop compliant novel ways to comply with regulatory requirements.
- 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.
- Oversee Just’s equipment management program to ensure manufacturing equipment is in a state of control, including reviewing and approving equipment calibration and preventative maintenance documents.
- 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.
- Provide oversight for equipment process changes and the potential impact to the validated state.
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 qualification or validation deliverables in a biologics environment.
- 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.
- Experience presenting and defending topics to external auditors around qualification and validation strategies.
- 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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