Validation Engineer III

The Role

We’re looking for a passionate and curious Validation Engineer III to join our team. If you’re excited by new challenges, solving complex problems, and learning every step of the way, you might just be the perfect fit. In this role, you’ll have the opportunity to drive impactful projects, collaborate with bright minds, and explore uncharted territories.

What You’ll Do

• Lead the generation of key deliverables in a phase-appropriate compliance manner as part of global CQV strategy for F&U, Equipment, QC/Analytical, Cleaning and Shipping
• Document a strategy for validations programs including the generation of validation master plans
• 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 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

Who You Are

• Bachelor’s degree in engineering science or related program with the following years in relevant experience: Validation Engineer III - 7+ 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
• Knowledge of process equipment, utilities, operations, and engineering principles
• A strong focus on quality and attention to detail
• 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
• 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
• Working knowledge of shipping and cleaning
• Working knowledge of process validation
• Working knowledge of utilities and facilities
• Working knowledge of computerized system
• Working knowledge of analytical equipment and systems

Pay & Benefits

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.