Jobs at Just - Evotec Biologics

As a Validation Engineer III, you'll play a key role in developing and executing validation strategies supporting late-phase and commercial biologics manufacturing, with a primary focus on cleaning validation. As part of a collaborative global Validation team, you'll partner across Operations, Logistics, Quality, Tech Transfer, Process Development, Engineering, and external vendors to develop and execute compliant, science- and risk-based validation programs.

You'll have the opportunity to take ownership of complex validation activities, lead investigations and problem-solving efforts, and contribute to validation strategies that support the growing biologics manufacturing network. The role may also support commissioning, qualification, and validation activities for manufacturing and laboratory equipment, facilities, utilities, and systems as business needs require.

• Lead the development and execution of phase-appropriate validation deliverables supporting global CQV strategies, with a focus on cleaning and shipping validation.
• Develop validation strategies and programs, including Validation Master Plans (VMPs) and supporting documentation.
• Liaise with the equipment, operations, logistics, qc, tech transfer, process development teams and third-party contractors, as applicable, to define and identify and perform cycle development, qualification and validation activities
• Author validation documentation including, but not limited to, risk and gap assessments, cycle development protocols / reports / procedures, qualification/validation protocols and reports, and validation discrepancies.
• Lead validation discrepancy resolution, including troubleshooting, root cause analysis, and development of appropriate corrective actions.
• Support the development of the qualification and validation programs at Just including the transition from paper based to digital validation software to configure globally scalable end to end paperless solutions to manage the validation lifecycle.
• Develop and strategize compliant and novel ways to comply with regulatory requirements.
• Support inspection readiness activities, Health Authority and Client audits, and support corrective actions based on audit findings.
• Lead CQV activities across global expansion sites.

• Bachelor's degree in engineering science or related program with 7+ years of relevant experience
• Strong technical expertise in cleaning validation within a GMP pharmaceutical or biologics manufacturing environment.
• Understanding of industry standards and best practices for a science and risk-based approach to qualification of systems and processes
• Working knowledge of US FDA CFRs and European EMA, including ICH regulations
• Experience with quality risk management
• Experience authoring, reviewing, and approving validation documentation
• Knowledge of process equipment, utilities, operations, and engineering principles
• Must possess a strong focus on quality and attention to detail
• Must possess problem-solving and critical thinking skills
• Motivated, self-starter with strong mechanical aptitude
• Ability to work both independently and collaboratively across multiple disciplines in a fast-paced and dynamic environment
• Excellent interpersonal, team, and communication skills are a must
• High level oral and written communication skills are a must
• Possess effective task/time management organizational skills

Additional Qualifications:

• Applies knowledge and expertise to solve complex technical problems
• Significant contributor to multi-disciplinary teams at the functional level
• Experience leading major validation projects or programs
• Working knowledge of process validation, utilities and facilities and analytical equipment/systems