Siegfried · 19 hours ago
Validation Engineer III, MS&T
Irvine, CA
Full-time
Onsite
Senior Level
$115K/yr - $135K/yr
5+ years expSiegfried is a global leader in pharmaceutical manufacturing, dedicated to upholding high standards in safety and quality. The Validation Engineer III will lead cleaning validation programs, oversee implementation of cleaning validation requirements, and drive continuous process improvements within the Manufacturing Science & Technology Department.
BiotechnologyHealth CareManufacturingMedicalPharmaceutical
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
Qualification
Required
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
Benefits
Medical, Dental, Vision
Flexible Spending & HSA Options
Life Insurance, Short & Long Term Disability
Pet Insurance
401K
Company
Siegfried
Siegfried is a leading CDMO with 13 production sites on three continents.
1001-5000 employees
H1B Sponsorship
Siegfried has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
2020 (1)
Funding
Current Stage
Public CompanyTotal Funding
unknown1995-04-07IPO
Leadership Team
Marcel Imwinkelried
CEO
Reto Suter
CFO
Recent News
2025-09-10
2025-08-21
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