Qualification and Validation Manager

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.

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

Executions and / or coordination of (specialized) process technology tasks

RESPONSIBILITIES

• Supervise, execute and coordinate qualification & validation activities by providing oversight of the site scheduled, requalification program and new equipment introduction.
• Demonstrates quality practices, ensure projects are compliant with inspection agencies’ (FDA, EU) requirements and Evonik practices
• Drafts technical documents such as Engineering Studies and GMP procedures
• Owns Deviations, CAPA’s, Change Controls and other deliverables to the Quality System
• Review and approve, protocols such as but not limited to, equipment qualification (IOQs), scheduled requalifications and test scripts.
• Review / analyze data generated from validation or qualification protocols and approve final summary report on Timely manner
• Adhere to Plans and SOP’s ensuring ongoing regulatory compliance (FDA/EU) with industry standards, practices and trends
• Support Continuous Improvement (CI) opportunities related to Facility equipment, materials management, yield and procedures.
• Maintain training on Evonik Quality and Compliance systems
• When required for assigned projects, support client audits in providing 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
• Establishes safety as the number one priority through training, actions and behaviors
• Adhere to all company safety, health and environmental policies, procedures and directives
• Ensures direct report tasks / validation tests are conducted 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 in science or engineering discipline
• 8+ years’ experience in the pharmaceutical industry in a validation role in an aseptic processing environment or equivalent.
• 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.
• 3-5 years of experience managing technical staff
• Excellent interpersonal skills, good computer skills
• Excellent written and verbal communication skills to communicate with both technical and non-technical internal and external client representatives
• Comprehensive knowledge of pharmaceutical manufacturing equipment, pharmaceutical processes, Aseptic Manufacturing, Parenteral Manufacturing and Contract Manufacturing
• Ability to work closely and effectively with other workgroups in order to successfully complete projects
• 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
• Proficient in the use of word processing, spreadsheet and presentation software programs.  Statistical software proficiency, a bonus
• A thorough understanding and application of relevant scientific theories, principles, and methods. 
• Capable of performing and applying standard scientific tests, procedures and techniques
• Knowledge of a variety of formulation, processing, analytical, and manufacturing equipment and instruments
• Ability to train personnel and supervise technical activities

The Evonik Group adopts an Equal Employment Opportunity (EEO) approach.  Candidates are assessed based on their educational qualifications, experience, job competencies and potential and shall not be discriminated against on the basis of race, ethnicity, age, gender, religion, nationality, disability or sexual orientation or other classifications protected by local, state, or provincial regulations.

Your Application
 

To ensure that your application is proceeded as quickly as possible and to protect the environment, please apply online via our careers portal. Further information about Evonik as Employer can be found at https://careers.evonik.com. 

Please address your application to the Talent Acquisition Manager, stating your earliest possible starting date and your salary expectations.

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