Senior Quality Engineer QEV

Just-Evotec Biologics (JEB) is seeking a highly-motivated Sr. 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 all 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 system qualification and validation efforts to enable the timely and compliant completion of Just-Evotec’s new biologics manufacturing across JEB network. (Hybrid or remote)

Job Responsibilities

• Apply extensive knowledge of technical & validation standards/requirements and industry guidance to influence the interpretation of governing requirements as it relates to Quality Systems & Validation.
• Understand JEB 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 of the installation, qualification/validation, operation and maintenance of GMP equipment, facilities, utilities and computerized systems; including infrastructure qualification.
• Review and approve qualification/validation documents, before and after execution, as required.
• Support process transfer from development to commercial drug substance manufacturing.
• Mentor functional groups in qualification/validation technical aspects, and compliance requirements.
• Partner with the biologics manufacturing sites on the implementation of new manufacturing and quality systems/equipment.
• Apply quality risk management principles to situations as the needs arise.
• Works collaboratively with both internal/external collaborators, vendors, and regulatory agencies to anticipate and resolve quality issues as well as maintain GMP compliance.
• Apply knowledge of GMP computerized systems, qualification and validation principles, manufacturing processes, quality systems, engineering design fundamentals, health authority expectations and industry standards
• Perform SDLC validation planning for each computerized system to ensure complete, successful end-to-end qualification of electronic systems, including system interfaces and infrastructure usage.
• Provide oversight to the overall site validation master plan, including interactions with other Just-Evotec entities responsible for related non-site-based computer systems.
• Perform risk assessments and data integrity evaluations in support of validation/qualification activities.
• Travel to JEB local and international sites as required.

The base pay range for this position at commencement of employment is expected to be $120,000 to $170,000; 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.