Duration
- 6-12+ Months – Possible extensions
Job Description
- Client is looking for a more of a Technical writer VS validation person that will be looking for vendor gaps on documentation, Existing IOQ docs, URS, etc. Traceability matrix and make addendum IOQs based on those gaps. This person will be rewriting them and make them more complete / compliant. They are trying to achieve with different equipment, blender, tablet press, etc. The client is buying the validation protocols from the vendors and will be doing wraps. The bulk of this role is identifying the gaps of the vendor protocols vs. what the client needs and writing those validations as well as executing them when the time comes.
- The Validation Engineer is responsible for the execution of the validation program activities, including but not limited to cleaning validations, process validations, and process qualifications. The Validation Engineer will interact with several functional areas and personnel within each ALI-PM department
Must
- Validation, Technical Writing, IOQ docs, URS, Traceability matrix and a combination of working with equipment, blender, tablet press, etc.
Essential Duties and Responsibilities
- Execute and support validation and investigation activities
- Support the collection of validation-related data and perform respective data and statistical analysis
- Oversee and support process qualification, process validation and cleaning validation protocols and develop summary reports, including corresponding periodic reviews
- Support process development activities in collaboration with other departments and other project teams
- Write technical protocols and reports and present results to diverse audiences of internal and external stakeholders
- Generate, update and approve standard operating procedures
- Manage and support change control, deviation and corrective and preventive actions development, out-of-specification and out-of-trend laboratory investigations, approvals and implementations
- Create and maintain user and process requirements and risk assessments
- Support equipment qualifications and calibration activities, as necessary
- Participate in and report Engineering department performance outputs with bracketing and trending during management reviews and Current Good Manufacturing Practices (cGMP) meetings
- Proactively propose and implement continuous improvements of quality systems and procedures
- Maintain compliance with ALI-PM’s policies and procedures
- As the workload demand changes for the department, additional responsibilities may be required
Omaha NE: Validation Engineer (235451)
