Validation Engineer III, MS&T

Validation Engineer III, MS&T page is loaded## Validation Engineer III, MS&Tlocations:
Irvine, CAtime type:
Full time posted on:
Posted Yesterday job requisition :
R26 41"Expect to grow", personally and professionally:
At Siegfried, we offer exciting challenges and ample opportunities to showcase your talents. As a trusted and respected partner to the pharmaceutical industry, we uphold the highest standards in safety, quality and sustainability, while fostering a culture that empowers you to thrive. Join a rapidly expanding global company, where diverse perspectives and experiences come together in a collaborative environment. Here, you'll find a workplace that values both collective success and your individual contributions—offering long-term opportunities to grow and make an impact.
** Your Role:
** Validation Engineer III is an onsite position in Irvine, CA.
The Validation Engineer III within Manufacturing Science & Technology (MS&T) Department provides the site with knowledge and expertise required to lead cleaning validation programs for our diverse portfolio encompassing pharmaceutical process development, technology transfers, and commercial products. This individual will oversee implementation of cleaning validation requirements by designing, planning, executing, and interpreting scientific reports or experiments to contribute to the overall success of MS&T Validation organization.

They will also play a key role in driving continuous process improvements and innovation for the cleaning validation program Irvine manufacturing site. This client-facing position requires an advanced level of proficiency in cleaning validation requirements for late-stage process development, clinical and commercial manufacturing operations as well as excellent interpersonal skills.
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* Your Profile:

***** Responsibilities
* *** Serve as a subject matter expert for the site cleaning validation program by overseeing the cleaning master plan, and cleaning validation strategies for clinical, product launches, and commercial programs.
* Build scientific knowledge and increase technical know-how of cleaning validation program at Irvine site. Support cleaning validation lifecycle activities by ensuring a state of control is maintained through ongoing process verification. Ensure appropriate KPIs are identified for ongoing monitoring.
* Author and review process and cleaning validation and verification protocols & reports. Participate in the creation of manufacturing procedures and SOPs for cleaning processes. Own and support the cleaning validation program data and associated trend analysis.
* Provide technical training to Production personnel and support execution of cleaning validation activities on the manufacturing floor
* Maintain all activities and projects pertaining to cleaning validation in an inspection ready status, including KPI reporting.
* Provide technical expertise and facilitate pre-validation risk assessments using appropriate risk management tools. Work collaboratively and cross functionally to help ensure that process risks are analyzed, adequately controlled, and appropriately documented.
* Ensure that all Site validation activities are performed and are in line with the current Siegfried Global requirements and cGMP, manage deviations associated with cleaning validation and makes recommendations for deviation resolution as well as prevention of reoccurrence.
* Own deviations, CAPAs, and audit responses related to cleaning validation program. Support on-the-floor troubleshooting and root-cause investigations.
*** Required Knowledge, Skill, and Abilities
**** Strong understanding and hands-on experience in cleaning validation activities for GMP manufacturing or process development of parenteral products, including the quality attributes and manufacturing controls for pharmaceuticals or biologics.
* Working knowledge of risk-based decision-making and stage-appropriate implementation of cleaning validation strategies, including modifications of existing processes and validation as applicable
* Familiarity with Annex 1 and FDA regulations (Validation of Cleaning Processes (7/93)) as it pertains to cleaning…