Validation Specialist
21 hours ago
At Intellectt Inc, we are seeking a highly skilled Validation Engineer to join our team. As a key member of our project team, you will be responsible for ensuring the quality and compliance of our water pretreatment systems, high quality steam systems generation and distribution, and water for injection systems.
Key Responsibilities:
- Support project activities within a cross-functional project team to ensure timely completion and quality delivery.
- Develop and implement project strategies in accordance with current standard operational procedures.
- Perform verification activities to support the start-up, commissioning, and qualification of water pretreatment systems, high quality steam systems generation and distribution, and water for injection systems.
- Collaborate with clients and design/construction companies to ensure technical meetings are conducted effectively.
- Control project progress and resource planning to ensure efficient delivery.
- Follow standard operating procedures and standards in a highly regulated environment to ensure compliance.
- Support the project team in protocol generation, revision, execution, and approval.
- Develop new standard operating procedures associated with the scope of work.
- Contribute to the interpretation of results and the design of subsequent project phases.
- Request, evaluate, and share technical information with the project team.
- Perform all tasks in strict compliance with best practices and regulatory requirements.
- Provide feedback to client leadership regarding potential issues and concerns with documentation elaboration and tasks execution.
- Adhere to safe work practices.
About You:
- Bachelor's degree in engineering, science, or a related field.
- At least 6 years of experience in qualification activities for Pharmaceutical Industries.
- Experience in commissioning and qualification activities related to water pre-treatment systems, high quality steam systems generation/distribution, and water for injection systems.
- Ability to interpret engineering drawings and discuss technical solutions associated with WFI systems.
- Hands-on experience in the development of Life Cycle documents such as Project Validation Plans, User Requirement Specifications, and Risk Assessments.
- Hands-on experience in the elaboration and execution of FAT, Commissioning, SAT, Installation Qualification, Operational Qualification, and Performance Qualification Protocols and Qualification Reports.
- Hands-on experience in evaluation of welding activities, procedures, and welding documentation.
- Hands-on experience in the elaboration of Standard Operating Procedures for operation and maintenance of WFI systems.
- Strong understanding of FDA regulations for commissioning, validation, and lifecycle management of GMP equipment and systems.
- Knowledge in WFI guidelines from International Society of Pharmaceutical Engineering.
- Ability to manage resource planning, priorities, deliverables, and project schedule milestones.
- Strong interpersonal, verbal communication, and technical writing skills.
- Fluency in English (reading, speaking, and writing) is a must.
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