Sr. Validation Engineer II
Takeda
August 21, 2026
On-site
Thousand Oaks, CA
$116,000 - $182,270 USD yearly
Operations
About the Role
Supports operations from initial qualification through validation maintenance of equipment, systems, facilities, and utilities. Performs CD, DQ, Commissioning/Qualification, PQ/CV, and Validation Maintenance with right-first-time and continuous improvement.
How you will contribute
- Lead execution of CD/PQ/CV/PV/RV activities.
- Act as project manager for validation deliverables; manage timelines/forecasts.
- Supervise/manage contractors or consultants.
- Participate in change control review board; own validation change control tasks.
- Track/trend activities; report issues impacting timelines.
- Serve as Validation Engineering representative/SME for cross-functional and multi-site teams.
- Apply expert judgment; troubleshoot and direct resolution of validation issues.
- Maintain inspection readiness; act as SME in Health Authority inspections.
- Review/approve commissioning documents (protocols/reports); evaluate testing for qualification.
- Generate and manage project plans/timelines for CD/DQ/IQ/OQ/PQ/CV and Validation Maintenance; change management documentation.
- Support departmental/capital project validation; provide validation KPIs.
- Coordinate tactical activities (e.g., sample collection, data/results retrieval, documentation).
- Coordinate re-qualification; support continuous learning; support EHS programs and own CAPA records as needed.
- Manage time, prioritize tasks, and meet goals; follow Takeda standards; may perform other duties.
What you bring to Takeda
- BS engineering + 10+ years validation experience (required).
- Desirable: LIMS, MES, ERP, SCADA, or DCS (e.g., Delta V).
- Required: advanced knowledge of equipment/computerized systems/facilities/utilities in regulated environments; commissioning and qualification.
- cGMP/regulatory validation knowledge; ability to define validation approaches; basic stats/data understanding.
- Strong problem-solving, collaboration, independent evaluation, and communication (verbal/written); proficiency in MS Word/Excel.
Benefits (as stated)
- Medical/dental/vision; 401(k) with match; disability/life insurance; tuition reimbursement; paid volunteer time off, holidays, well-being benefits; up to 80 hours sick time; up to 120 hours paid vacation (new hires).
Supports operations from initial qualification through validation maintenance of equipment, systems, facilities, and utilities. Performs CD, DQ, Commissioning/Qualification, PQ/CV, and Validation Maintenance with right-first-time and continuous improvement.
How you will contribute
- Lead execution of CD/PQ/CV/PV/RV activities.
- Act as project manager for validation deliverables; manage timelines/forecasts.
- Supervise/manage contractors or consultants.
- Participate in change control review board; own validation change control tasks.
- Track/trend activities; report issues impacting timelines.
- Serve as Validation Engineering representative/SME for cross-functional and multi-site teams.
- Apply expert judgment; troubleshoot and direct resolution of validation issues.
- Maintain inspection readiness; act as SME in Health Authority inspections.
- Review/approve commissioning documents (protocols/reports); evaluate testing for qualification.
- Generate and manage project plans/timelines for CD/DQ/IQ/OQ/PQ/CV and Validation Maintenance; change management documentation.
- Support departmental/capital project validation; provide validation KPIs.
- Coordinate tactical activities (e.g., sample collection, data/results retrieval, documentation).
- Coordinate re-qualification; support continuous learning; support EHS programs and own CAPA records as needed.
- Manage time, prioritize tasks, and meet goals; follow Takeda standards; may perform other duties.
What you bring to Takeda
- BS engineering + 10+ years validation experience (required).
- Desirable: LIMS, MES, ERP, SCADA, or DCS (e.g., Delta V).
- Required: advanced knowledge of equipment/computerized systems/facilities/utilities in regulated environments; commissioning and qualification.
- cGMP/regulatory validation knowledge; ability to define validation approaches; basic stats/data understanding.
- Strong problem-solving, collaboration, independent evaluation, and communication (verbal/written); proficiency in MS Word/Excel.
Benefits (as stated)
- Medical/dental/vision; 401(k) with match; disability/life insurance; tuition reimbursement; paid volunteer time off, holidays, well-being benefits; up to 80 hours sick time; up to 120 hours paid vacation (new hires).