Just is seeking a highly-motivated Quality Engineer within the Global Quality Engineering & Validation 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 facility, utility, and equipment (FUE) 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.
- 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 Annex 15, 21 CFR Part 210 and 211, 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.