Specialist II/III, (Validation) - Cleaning
Provides validation lifecycle of processes including: Process validation, Aseptic validation, Cleaning validation, and Shipping validation.
Provides support of equipment qualification as needed.
*Level will be determined by years of experience.Major Accountabilities:
- Provide technical input in one or more programs including Process Validation, Aseptic Validation, Cleaning Validation, and Shipping Validation:
- Writing and executing validation plans, protocols, and writing summary reports, in accordance with approved procedures
- Evaluation, implementation, and support of change controls and investigations
- Active member of integrated team where interaction with various groups is required to coordinate, plan, and execute work including new facilities or complicated changes
- Ensures that current industry standards are reviewed and implemented
- Support regulatory filings
- Maintenance of lifecycle documentation (e.g. validation plans)
- Participation in regulatory inspections
- Provide technical support to the Seqirus network and Contract Manufacturing Organizations (CMO’s):
- Provide technical support to Seqirus network sites
- Oversight of tech transfer validation to CMOs
- Participate in site and departmental objectives which may preclude scope of expertise.
- Support equipment / automation validation in either QC, facilities, fill finish, or bulk manufacturing
- Build and maintain relationships with stakeholders including Operations, MS&T, and Quality.
- Bachelor’s degree is required in Engineering, technical or science related field.
- Minimum of 5 years of direct validation experience in one or more of the following validation programs: process, aseptic, cleaning, and shipping.
- Previous experience using an integrated qualification approach required.
- Program ownership and/or interaction with regulatory agencies preferred:
- Inspection defense
- Authoring responses
- Strategy building in partnership with Regulatory Affairs
- Provides input to business problems by sharing functional knowledge with others in own professional discipline
- Travel may be required on occasion (minimal)
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