Senior Validation Specialist
hace 2 meses
We are seeking a highly skilled Sr Validation Scientist to join our team at Validation & Engineering Group, Inc. As a key member of our Validation & Engineering Group, you will be responsible for ensuring the highest standards of quality and compliance in our clients' products and processes.
About the Role:
In this role, you will have the opportunity to work on a wide range of projects, from laboratory to commercial manufacturing, and contribute to the development of new products and services. You will be expected to apply your technical expertise to solve complex problems, collaborate with cross-functional teams, and provide leadership and guidance to junior team members.
Key Responsibilities:
- Develop and implement validation strategies and protocols to ensure compliance with regulatory requirements.
- Conduct risk assessments and develop mitigation plans to address potential risks and non-conformities.
- Collaborate with engineering, quality, and regulatory teams to ensure seamless project execution.
- Provide training and support to team members on validation procedures and best practices.
- Identify areas for process improvements and implement changes to enhance efficiency and effectiveness.
Requirements:
- Doctorate degree or Master's degree and 3 years of directly related experience or Bachelor's degree and 5 years of directly related experience.
- Preferred educational background: Engineering (any field) or scientific background (Biology, Microbiology, Biotechnology, Chemistry, etc.).
- Previous experience in regulated environments (Biotechnology, Pharmaceutical, Medical Devices, etc.).
- Experience in Validation with preference in Process Validation.
- Advanced validation knowledge (equipment qualification, cleaning, sterilization).
- English speaking and writing is a must.
Skills:
- In-depth knowledge of validation processes and requirements.
- Ability to interact effectively with various communication and working styles.
- Ability to handle multiple projects at one time.
- Ability to provide solutions to a large variety of technical problems of moderate to large complexity and scope.
- Problem-solving skills requiring the application of scientific and engineering theory and calculations and creative skills in the development of hypotheses and approach.
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