Sr. Qualification and Validation Specialist

What we offer

Explore a world of opportunities with us. Look ahead with us and help shape innovative solutions to make our world more sustainable and life healthier, more vibrant and more comfortable. At Evonik, you have the chance to explore, thrive, and grow alongside 33,000 colleagues. Among attractive career paths and high-quality development programs, we not only offer performance-based remuneration and occupational health benefits but also hybrid and flexible working environments with #SmartWork. Bring your fresh perspective, develop your strengths, break out your mold, and find a career that fits your dreams with us.

Click on the link below to learn what our employees have to say about Evonik:

https://careers.evonik.com/en/about/meet-the-team/

Plan, direct, or coordinate qualification and validation programs. Formulate internal policies i compliance with regulatory agencies and Evonik policies.

RESPONSIBILITIES

• Develop Qualification & Validation Plans, Procedures and Projects and support or improve existing ones
• Coordinate and Execute Validation and / or Qualification activities / requirement, ensuring activities are on time, within budget, and meet cGMP requirements
• Demonstrates quality practices, ensure projects are compliant with inspection agencies’ (FDA, EU) requirements and Evonik practices
• Drafts technical documents such as engineering studies, qualification / validation protocols and summary reports
• Owns Deviations, CAPA’s, Change Controls and other deliverables to the Quality System
• Prepare, execute protocols such as but not limited to, Performance Qualification (PQ), scheduled requalifications and test scripts.
• Summarize / analyze data generated from validation or qualification protocols and prepare final summary report on Timely manner
• Perform peer review for Specialist and provide technical guidance as SMEs in their area.
• Support Continuous Improvement (CI) opportunities related to Facility equipment, materials management, yield and procedures.  Support improvements implementations.
• Maintain training on Evonik Quality and Compliance systems.
• When required for assigned projects; support clients audits by representing the department as subject matter experts and provide applicable documentation relevant to validation or qualification activities.
• Maintain current Validation knowledge through review of current Pharmaceutical, Engineering, Scientific literature, and by participating in Professional events, i.e. ISPE, ASQ, PDA, etc.
• Adhere to all company safety, health and environmental policies, procedures and directives
• Conduct assigned tasks / validation tests in a safe manner by use of MSDS to establish chemical hazards; observe the appropriate laboratory procedures; and report all incidents that could threaten the safety of personnel

REQUIREMENTS:

• Bachelor’s degree (or higher) preferably in Science or Engineering discipline.  Other disciplines and/or equivalent job experience will be considered.
• 5 to 7 experience in validation of aseptic pharmaceutical processes and / or equipment qualification
• Strong understanding of Regulatory Guidance Framework FDA/EU, Industry Best Practices and cGMPs
• Strong problem-solving and critical thinking skills with demonstrated ability to conduct technical programs and to achieve program goals; strong organization skills to handle and delegate multiple projects at differing levels of complexity
• Excellent interpersonal skills
• Effective written and verbal communication skills; ability to clearly and effectively communicate observations and outcomes to all levels of employee within the company
• Comprehensive knowledge of pharmaceutical manufacturing equipment and processes
• Ability to work closely and effectively with other workgroups in order to successfully complete projects on time and thoroughly
• Knowledge of the use of personal protective equipment and safety practices related to working with or exposure to hazardous materials that may potentially affect the health of the employee
• Ability to:
  • Work independently or within a team environment;
  • Perform work utilizing a computer for extended periods of time;
  • Sit for extended periods of time without being able to leave the work area;
  • Stand for extended periods of time without being able to leave the work area;
  • Grasp objects utilizing the fingers (fine motor manipulation);