Validation Engineer III, MS&T

"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.

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 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.

Required Education and Experience

• 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.

Target Salary Range: $115,000 - 135,000

Your Benefits: 

• Medical, Dental, Vision
• Flexible Spending & HSA Options
• Life Insurance, Short & Long Term Disability
• Pet Insurance
• 401K

Founded in 1873 in Zofingen, Switzerland, Siegfried has grown into a global network of 13 sites across three continents. With a team of more than 3,800 highly skilled professionals, we take the innovations of our pharmaceutical customers to industrial scale and manufacture safe drugs for patients worldwide. As a fully integrated CDMO, Siegfried is one of the few organizations today that can carry out the development and manufacturing of APIs and finished dosage forms under one roof. This unique combination of know-how and experience makes us the most trusted partner in the pharmaceutical industry.