Cleaning Validation Specialist
2 days ago
The Cleaning Validation Specialist** **is responsible for optimizing cleaning cycle development and cleaning validation in pharmaceutical industries. This individual will generate and execute cleaning validation protocols and report on testing results. The individual will coordinate sampling and will execute required sampling techniques. The individual will generate and resolve protocol discrepancies or non-conformances and generate investigation reports based on a sound investigation and impact assessment. The individual will ensure that projects are implemented in accordance with the agreed scope and within the pre-determined timelines, policies and procedures. The position involves training operations staff on protocols, procedures and technical details related to cleaning processes.
- **Responsibilities**:
- Develop risk assessments, cleaning validation plans and review flow paths for system cleanability
- Optimize cleaning cycles to reduce water, chemicals and time.
- Develop and execute cleaning validation protocols for pharmaceutical cleaning equipment and processes.
- Assess protocol discrepancies/non-conformances, investigate the non-conformances, assess the impact to the validation study and develop investigation reports.
- Coordinate sampling plans for multiple projects
- Execute sampling techniques required for cleaning validation studies. (rinse and swab sampling)
- Review, analyze and interpret system performance data for completed cleaning validation studies and prepare final report packages.
- Review GxP deliverables including specifications, drawings, procedural documents, master plans, and validation documentation.
- Perform system and P&ID walkdowns and produce layout drawings and process maps.
- Suggest design alternatives that would lead to reduce water, chemical use and time
- Promote cGMP and regulatory compliance into assigned projects.
**Qualifications**
- BS degree or higher in Biochemistry or a related engineering discipline, or significant related experience
- Experience in GxP environment such as pharmaceutical/biotechnology
- Ability to work on complex or undefined problems and quickly identify and address critical issues
- Ability to create an environment of trust, compliance, continuous improvement, and learning
- Ability to pivot mindset and project goals to assist in compliance troubleshooting
- Environmentally friendly mindset to optimize use of energy and components
- Demonstrated ability to manage multiple priorities with aggressive timelines
- Demonstrated ability to work individually or in a team setting
- Effective written and oral communication skills; ability to write, type, express or exchange ideas; ability to convey information/instructions accurately
- Ability to relate with people at all levels within an organization, including diverse cultures
- Willingness to travel as needed
Hyde Engineering + Consulting is an equal opportunity, affirmative action employer.
LI-JS1
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