Quality Engineer/Senior Quality Engineer, Quality Engineering & Validation (CSV)

Location
Redmond, WA
Posted
Jun 08, 2022
Ref
REQ-05675
Hotbed
BioForest
Required Education
Bachelors Degree
Position Type
Full time

Just is seeking a highly-motivated individual to join the Quality Engineering and Validation organization with a focus on Computer Systems Validation that desires to be part of a team focused on improving worldwide access to Biotherapeutics! The role will be primarily responsible for providing technical and Quality Assurance oversight of the execution of CSV activities for GxP regulated computerized systems, 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 for enterprise and local computerized systems validation in a GxP regulated biologics environment within the Just-Evotec manufacturing network.

Responsibilities

  • Support enterprise, cross functional, and local computer systems validation activities, in providing approach, methodology, and deliverables in compliance with GxP, 21 CFR Part 11, Annex 11, and Data Integrity principles.

  • Develop compliant novel ways to comply with regulatory requirements.

  • Partner with project teams to provide solutions for validation of systems following a risk-based approach as established in Just-Evotec policy documents and procedures.

  • Apply extensive knowledge of technical & validation (PQS) standards/requirements and industry guidance to influence the interpretation of governing requirements as it relates to computer system validation.

  • Implement and maintain the PQS as it pertains to systems validation for Just.

  • Develop validation documents (plans, qualification, UAT, test cases, traceability matrix, and summary reports) with functional teams, ensuring the documentation meets compliance requirements and quality standards.

  • Provide Quality oversight in change control activities to ensure technical and document impact assessments are performed in a compliant manner and the regulated systems are maintained in a validated state.

  • Mentor QC 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.

  • 5+ years relevant experience in a biopharmaceutical cGMP manufacturing or similar environment.

  • Experience authoring, reviewing, and approving qualification or validation deliverables in a biologics environment.

  • Proven work experience in software quality assurance.

  • Knowledge of FDA guidance’s and industry standards (e.g. quality Systems, GAMP, 21 CFR Part 11 and EudraLex Volume 4 Annex 11).

  • Knowledge of Data Integrity principles and applications in computer systems.

  • Solid technical understanding of GMP biologics manufacturing processes and equipment.

  • Proven track record to create, review, and execute qualification protocols (IQ/OQ/PQ) and associated validation lifecycle documentation, including identification and resolution of non-conformances/deviations.

  • 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.


Worker