Manager/Sr. Manager, Quality Engineering & Validation (QEV)

Just is seeking a highly motivated leader to join the Global Quality Engineering and Validation organization that desires to be part of a team focused on improving worldwide access to Biotherapeutics! The role within the QEV organization will be focused on Facilities, Utilities and Equipment (FUE) and will be primarily responsible for validating FUE equipment, mentoring a team of Quality Engineers, and building/enhancing the Just-Evotec FUE Validation lifecycle process.

Responsibilities

• Responsible for maintaining and ensuring site compliance to corporate policies and procedures for the validation of FUE systems.
• Support enterprise, cross functional, and FUE validation activities, in providing approach, methodology, and deliverables in compliance with 21 CFR Part 11, 58, 210 and 211, Eudralex regulations and ICH guidelines.
• Define the strategy for FUE systems at Just-Evotec and work with stakeholders to implement.
• Build, teach, and act as a resource for a team of 2-4 Quality Engineers with varying experience levels.
• 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 FUE systems validation.
• Implement and maintain the PQS as it pertains to systems validation for Just.
• Oversee 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.
• Provide Quality guidance, strategy, and presentation of topics during external audits.

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+ years relevant experience in a biopharmaceutical cGMP manufacturing or similar environment.
• Proven work experience in FUE validation.
• Experience authoring, reviewing, and approving qualification or validation deliverables in a biologics environment.
• Knowledge of FDA guidance’s and industry standards (e.g. quality Systems,, 21 CFR Part 11 and EudraLex Volume 4 Annex 11).
• 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.

The base pay range for this position at commencement of employment is expected to be $145,000 to $175,000; Base salary offered may vary depending on individual’s 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.