Senior Validation Engineer - Process

Just is seeking a highly motivated Validation Engineer that desires a significant opportunity to improve worldwide access to biotherapeutics. A few focus areas of this job include to strategize, implement and support cleaning, shipping and process validation activities required for late phase and commercial biologics manufacturing as part of a fast-paced and collaborative global validation team. Manufacturing and laboratory equipment, systems, facilities, and utilities commissioning, qualification and validation activities maybe supported as part of this role as required.

Roles Primary Responsibilities:

• Lead the generation of key deliverables in a phase appropriate compliance manner as part of global CQV strategy for Process, Cleaning and Shipping Validation
• Document a strategy for cleaning, shipping and process validation programs including the generation of validation master plans
• Liaise with the operations, logistics, qc, tech transfer, process development teams and third-party contractors, as applicable, to define and identify hold times, mix times, cleaning methods, shippers, 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 and root cause analysis
• 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

Education and Qualification Requirements:

Bachelor’s degree in engineering science or related program with the following years in relevant experience:

• Sr Validation Engineer - 8+ years
• 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 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
• Led a team or large validation projects
• Direct knowledge of shipping and transport logistics
• Direct knowledge of cleaning validation methodologies
• Direct knowledge of process validation
• Working knowledge of utilities and facilities
• Working knowledge of computerized system
• Working knowledge of analytical equipment and systems

This job description is intended to describe the general content of the job, and to identify the essential functions of and requirements for the performance of this job. It is not to be construed as an exhaustive statement of duties, responsibilities, or requirements. Because job requirements evolve with the changing needs of Just-Evotec Biologics business, this description is subject to change and may be modified at any time, whether formally or informally.

The base pay range for this position at commencement of employment is expected to be $111,360 to $159,000; Base salary offered may vary depending on the 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.