03/03/2025
🚨Role: Process Validation Engineer
Location: LA
Essential Responsibilities -
• Ensure that all qualifications and validations are performed according to the regulatory and customer requirements
• Be able to support Quality by Design on the drugs to be transferred or developed on the site
• Write qualification and validation protocols/reports and other documentation related to the activities
• Validation of aseptic process (formulation, filling, holding times)
• Participate to shutdown qualification & calibration activities
• Investigate deviations as needed and execute corrections
• Define and execute improvement projects and initiatives
• Ensure that all activities are performed in time and due quality
Qualifications
• BS in Engineering, Science or equivalent technical degree.
• 2-5+ years’ experience in a regulated, manufacturing environment within the biotechnology, pharmaceutical or medical device industry.
• Experience in the areas of design documentation (URS, FS, DS and other engineering specifications) Validation (IQ, OQ, PQ, PV, CV, CSV, etc.), Quality Systems (Change Control, Non-Conformances, Requalification, etc), and Process Excellence Methodologies (Six-Sigma, Lean, etc.).
📧 Interested or know someone who is? Tag them or apply now!
❗ Important Notice for Third-Party Vendors ❗
Third-party vendors, PLEASE DO NOT APPROACH. The selected consultant will be our employee on our payroll, and we are not engaging in C2C arrangements with third-party vendors.
📩 How to Apply:
👉DM us for inquiries or to apply directly.
👉Email your updated resume to [email protected] if you’re interested.