Process Validation Engineer
Description
Process Validation Engineer (Los Angeles Area)
Azzur Group is a GxP compliance and consulting organization dedicated to delivering high-quality, expertly-backed solutions that drive life science companies to success. We are seeking motivated and talented individuals to join our team of skilled problem solvers, supporting key clients in pharmaceutical manufacturing. Qualified candidates must have a desire to learn, adapt, and excel in the fast-paced, evolving healthcare industry while embodying Azzur’s core values: Put Others First, Have the Courage to Take Action, Take Personal Responsibility, and Have Fun!
Requirements/Expectations of the Role
● Responsible for performing process and equipment validation activities including, but not limited to, gathering historical data for product manufacture, analyzing data using statistical principles, writing validation protocols and reports
● Author validation plans; assist with the development of specifications for user requirements, functional requirements, design requirements, and cycle development protocols for manufacturing process steps.
● Leverage statistical tools/software such as MiniTab for the development of process validation strategies
● Ensure all qualifications and validations are performed according to regulatory and customer requirements
● Lead cross-functional review and implementation/execution of documentation with clients or internal stakeholders
● Support Quality by Design on the drugs to be transferred or developed on the site
● Support risk assessments and pFMEAs generations
● Compare results against acceptance criteria and lead the resolution of deviations
● Recommend to QA the release of qualified systems
● Validation of aseptic process and DS/DP manufacturing process (formulation and mixing studies, filling, buffer/media/process holding times)
● Review validation packages for completeness and accuracy, GDP, scientific rationale, compliance with validation policies and procedures, and accurate data analysis
● Compile, maintain, analyze, and make recommendations for value-generating solutions based on data from multiple sources supporting engineering and validation work
● Investigate deviations as needed and execute corrections independently
● Define and execute improvement projects and initiatives
Qualifications
● BS in Engineering, Science, or equivalent technical degree.
● 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.).
● Excellent written and verbal communication skills; excellent technical writing skills.
● Strong interpersonal skills and the ability to work in a team environment.
● Ability to work effectively in a fast-paced multitasking environment.
● Strong working knowledge of FDA and cGMP regulations and documentation practices.
● Proficient in Microsoft Word, Excel, PowerPoint.
● Working for multiple clients throughout the region.
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