Validation Engineer III, MS&T

Siegfried•Irvine, CA

6d•$115,000 - $135,000•Onsite

About The Position

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.

Requirements

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 validation implementation
Capable of working with global and cross-functional teams in dynamic and time-bound environments.
Capable of building effective working relationships across departments (QA, Project Management, Business Development, and Manufacturing) to support the introduction of new processes and products.
Experience with root cause analysis and product quality impact assessments for deviations and investigations utilizing Lean Six Sigma tools.
Capable of identifying issues, providing solutions, and forward thinking through solid problem solving.
Able to effectively communicate with internal and external clients on matters concerning technical feasibility and GMP readiness for cleaning validation program
Working knowledge of GMP production-related IT systems such as SAP and LIMS is desired.
Bachelor's Degree in Engineering or science-related field with seven years of industry experience or Master's degree with five years of industry experience.
Minimum of four years of hands-on experience supporting cleaning validation activities for Fill/Finish or Aseptic Process operations, preferably in commercial GMP manufacturing.
Equivalent education or experience may substitute the stated requirements.

Nice To Haves

Working knowledge of GMP production-related IT systems such as SAP and LIMS is desired.

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.