- 01We’re looking for a passionate and curious Validation Engineer III to join our
- 02team. If you’re excited by new challenges, solving complex problems, and
- 03learning every step of the way, you might just be the perfect fit. In this role,
- 04you’ll have the opportunity to drive impactful projects, collaborate with bright
- 05minds, and explore uncharted territories.
- 06As a Validation Engineer III, you’ll play a key role in developing and executing
- 07validation strategies supporting late-phase and commercial biologics
- 08manufacturing, with a primary focus on cleaning validation. As part of our
- 09collaborative global Validation team, you’ll partner across Operations,
- 10Logistics, Quality, Tech Transfer, Process Development, Engineering, and
- 11external vendors to develop and execute compliant, science- and risk-based
- 13You’ll have the opportunity to take ownership of complex validation activities,
- 14lead investigations and problem-solving efforts, and contribute to validation
- 15strategies that support our growing biologics manufacturing network. The role
- 16may also support commissioning, qualification, and validation activities for
- 17manufacturing and laboratory equipment, facilities, utilities, and systems as
- 18business needs require.
What You’ll Do
- 19Lead the development and execution of phase-appropriate validation deliverables supporting global CQV strategies, with a focus on cleaning and shipping validation.
- 20Develop validation strategies and programs, including Validation Master Plans (VMPs) and supporting documentation.
- 21Liaise 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
- 22Author validation documentation including, but not limited to, risk and gap assessments, cycle development protocols / reports / procedures, qualification/validation protocols and reports, and validation discrepancies.
- 23Lead validation discrepancy resolution, including troubleshooting, root cause analysis, and development of appropriate corrective actions.
- 24Support 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.
- 25Develop and strategize compliant and novel ways to comply with regulatory requirements.
- 26Support inspection readiness activities, Health Authority and Client audits, and support corrective actions based on audit findings.
- 27Lead CQV activities across global expansion sites.
Who You Are
- 28Bachelor’s degree in engineering science or related program with the following years in relevant experience: 7+ years
- 29Strong technical expertise in cleaning validation within a GMP pharmaceutical or biologics manufacturing environment.
- 30Understanding of industry standards and best practices for a science and risk-based approach to qualification of systems and processes
- 31Working knowledge of US FDA CFRs and European EMA, including ICH regulations
- 32Experience with quality risk management
- 33Experience authoring, reviewing, and approving validation documentation
- 34Knowledge of process equipment, utilities, operations, and engineering principles
- 35Must possess a strong focus on quality and attention to detail
- 36Must possess problem-solving and critical thinking skills
- 37Motivated, self-starter with strong mechanical aptitude
- 38Ability to work both independently and collaboratively across multiple disciplines in a fast-paced and dynamic environment
- 39Excellent interpersonal, team, and communication skills are a must
- 40High level oral and written communication skills are a must
- 41Possess effective task/time management organizational skills
Additional Qualifications
- 42Applies knowledge and expertise to solve complex technical problems
- 43Significant contributor to multi-disciplinary teams at the functional level
- 44Experience leading major validation projects or programs
- 45Working knowledge of process validation, utilities and facilities and analytical equipment/systems
Why Join Us
- 46Growth Opportunities: We’re a company that believes in continuous learning and development. Whether it’s professional courses, mentorship, or new projects, we’ll help you grow.
- 47Inclusive Culture: We’re committed to building a diverse and inclusive environment where everyone’s voice is valued, and curiosity is encouraged.
- 48Innovative Projects: You’ll have the chance to work on groundbreaking initiatives and cutting-edge technology in an atmosphere where your curiosity is the key to success.
- 49A Place for Big Ideas: We don’t just talk about thinking outside the box—we throw the box away. If you’ve got ideas, we want to hear them.
Are You Still Curious?
If you’ve read this far, then chances are you’ve got a curious mind, just like us. So, what are you waiting for? Take the leap and apply today. We can’t wait to see where your curiosity leads you and how it will shape the future of Just-Evotec.
Let your curiosity guide your career #BeCurious and explore the endless possibilities at Evotec!
The base pay range for this position at commencement of employment is expected to be $115,000 to $126,500; 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.
Estados Unidos
