Job Title: Senior Validation Engineer
Location: Thousand Oaks, California (Hybrid)
Job Summary: We are seeking a skilled professional to lead and execute commissioning and qualification activities for new or modified GMP analytical and process equipment, utilities, and facilities. Our team is focused on supporting project goals by ensuring all compliance and documentation align with industry standards and regulatory requirements.
Responsibilities:
- Plan and track the implementation of commissioning and qualification actions and documentation in line with project timelines.
- Collaborate with project teams to develop commissioning and qualification strategies and prepare corresponding qualification plans.
- Generate, review, execute, and finalize protocols (IQ, OQ, FT, PQ) and reports for GMP equipment, utilities, and facilities.
- Prepare, evaluate, and approve technical documentation linked to GMP, including URS, FMEA, risk assessments, master plans, and validation records.
Required:
- Experience in a pharmaceutical, biotech, or life science organization in a commissioning/qualification/validation capacity.
- Demonstrated knowledge of cGMP commissioning, qualification, and validation practices.
- Familiarity with digital Commissioning & Qualification systems such as the Kneat Gx Platform or similar.
- One of the following education/experience combinations is required: Doctorate degree; or Master’s degree with 2 years of experience; or Bachelor’s degree with 4 years of experience; or Associate’s degree with 8 years of experience; or high school diploma/GED with 10 years of experience.
About SSI People: With over 26 years of industry experience, SSi People has built its reputation and expertise on putting people first. Everything we do works toward delivering exceptional experience for our consultants, our clients, and our internal team. Through a genuine commitment to people in everything we do. We have developed refined processes and a stellar internal team to deliver talent quickly. More importantly, we focus on building long-term relationships, not transactions. Putting people first is just what we do well.
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