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Job Description
Overall Purpose of the Job:
- Responsible for the conducts of the validation plan and processes for facilities, laboratory equipment, utility systems and process equipment, writes reports that reflect the validation was performed.
Primary Tasks:
- Write validation protocols and reports.
- Perform validation activities described in validation protocols including thermal studies, equipment and utilities validation.
- Maintain an up to date knowledge of validation requirements, practices and procedures.
- Work with validation and metrology contractors when required.
- Interact with manufacturing sciences and facilities / engineering departments to facilitate protocol execution as necessary.
- Write validation master plans related to specific projects and coordinate project meetings related to execution of the validation master plan.
- Write validation site specific and multi-site procedures.
- Support implementation of validated system change requests and resolution of process deviations through technical knowledge, execution of supporting validation studies, and manufacturing documentation review and approval.
- Good technical writing skills
- Able to read P&ID, Isometric and "as built" drawings.
- Communicate effectively with supervisor and other department's workload, priorities, and issues to maintain validation schedule.
- Filter validation.
- Sterility validation.
Job Requirements
- Bachelor degree in engineering.
- Minimum 2 year experience in technical project management.
- Excellent English, verbal / written communication
- Excellent computer skills.
- Ability to solve practical problems.
- Ability to interpret a variety of instructions furnished in written, oral, diagram or schedule form.
- Ability to work with mathematical concepts.
- Ability to apply concepts such as fractions, percentages, ratios and proportions to practical situations.