Sr. Validation Scientist - 33562

🌟 Job Title: Sr. Validation Scientist 33562

📍 Location: Hybrid Opportunity, with preference for onsite work

🕗 Shift: 8 hrs | 8 AM - 5 PM (Non-standard shifts may be required, including second/third shifts, weekends, and holidays to support new product introductions, project optimization, and commercial manufacturing).

👥 Positions Available: 2

⏳ Duration: Approximately six months

SUMMARY

In this role, you will independently provide or direct technical validation engineering support for process and/or equipment upgrades, replacements, and modifications in laboratory, manufacturing, or manufacturing support environments. You will have a key role in ensuring high standards of compliance and operational efficiency.

Preferred Qualifications

🎓 Educational Background:

• Engineering (any field) or a scientific discipline (e.g., Biology, Microbiology, Biotechnology, Chemistry).
• Prior experience in regulated environments (Biotechnology, Pharmaceutical, Medical Devices, etc.).
• Experience in Validation, with a preference for Process Validation.
• Doctorate degree or Master’s degree with 3 years of related experience,
• Bachelor’s degree with 5 years of related experience,
• Associate’s degree with 10 years of related experience, or
• High school diploma/GED with 12 years of related experience.
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Key Responsibilities

⚙️ Troubleshoot Systemic Validation Issues:

• Apply advanced validation engineering principles to design and implement significant system or process modifications.
• Develop, organize, analyze, and present interpretations of operational or validation project results.
• Complete complex assignments requiring new or improved validation engineering techniques.

🛠️ Project Leadership:

• Supervise and coordinate the work of small teams of engineers or technicians.
• Employ advanced validation engineering techniques and extend expertise to related fields.
• Develop technical solutions to complex challenges, requiring ingenuity and creativity.

🏗️ Collaboration & Cross-Departmental Work:

• Work closely with teams from manufacturing, process development, utilities, facilities, labs, and quality assurance to develop recommendations for complex process or system modifications.
• Ensure validation responsibilities for engineering projects are completed on time and within budget.
• Develop departmental or project budgets spanning multiple disciplines.

📊 Advanced Problem Solving:

• Provide technical solutions to a wide range of difficult problems, ensuring they align with organizational objectives.
• Exercise considerable discretion in determining technical objectives, with work reviewed for long-term results.

👩‍💼 Leadership & Impact:

• Lead a group of peers and may supervise staff or project resources.
• Guide the successful completion of major programs and represent the organization as the prime technical contact on contracts and projects.

Knowledge & Skills

🔍 Expertise in Validation Engineering:

• Strong knowledge of validation processes, including equipment qualification, cleaning, and sterilization.
• Ability to independently determine when additional internal or external resources are needed to solve problems.

🤝 Leadership & Communication Skills:

• Lead cross-functional teams and interact with senior external personnel on significant technical matters.
• Demonstrated ability to negotiate, resolve conflicts, and build strong teams.

📑 Regulatory Knowledge:

• Understand industry regulatory trends and align them with corporate direction.
• Experience working with FDA or other regulatory bodies and representing the organization as a technical expert.

Competencies/Skills

🏆 Key Skills for Success:

• Expertise in validation processes and strong technical problem-solving abilities.
• Effective communication and collaboration skills across diverse teams.
• Ability to handle multiple projects and independently determine resource needs.
• Strong project management, scheduling, and facilitation skills.
• Financial analysis tools and the ability to manage contractors and vendors.
• Demonstrated leadership in negotiation, decision-making, and team building.

📅 Prompt and regular attendance is essential.

Other duties may be assigned based on project needs.

Ready to take the next step? Apply today and join our client in shaping the future of pharmaceutical and biotech innovation! 🌍🚀