Process Validation Engineer
Description
Essential Duties and Responsibilities
Azzur personnel are expected to always live up to our core values and exhibit a high level of integrity and personal responsibility, especially when interacting with our valued clients. The following is a short list of the typical responsibilities and deliverables of any given project. The level of knowledge expected will be commensurate with level of incoming experience.
- 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
- 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, GDP review of data and reports, and final approval of validation protocols, reports, and deviations
- Author validation plans; assist with the development of specifications for user requirements, functional requirements, and design requirements, and cycle development protocols for manufacturing process steps.
- Support risk assessments and pFMEAs generations
- Leverage statistical tools/software such as MiniTab for the development of process validation strategies
- Validation of aseptic process & DS/DP manufacturing process (formulation & mixing studies, filling, buffer/media/process holding times)
- Review validation packages for completeness and accuracy, scientific rationale, compliance with validation policies and procedures, and accurate data analysis
- Compare results against acceptance criteria and lead the resolution of deviations
- Act independently to execute approved resolutions
- Recommend to QA the release of qualified systems
- Lead cross functional review and implementation / execution of documentation with clients or internal stakeholders
- 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
- Ensure that all activities are performed in time and due quality
Qualifications
- BS in Engineering, Science, or equivalent technical degree.
- 3-5+ 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.).
- 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.
Ideal Qualities
Ideal candidates will exhibit, or have the willingness to develop, the following qualities:
- Strategic thinker with strong analytical skills who can translate client needs into actionable value-added projects/results
- Willing to work hands on with multiple clients throughout Southern California
- Ensures activities are efficient, optimized, and client centric.
- Highly motivated and organized, solutions-oriented leader
- Curious and adaptable - can transform knowledge into actionable activities
Able to produce results in a fast paced, collaborative environment
Learn more about who we are and what makes us great here: https://www.youtube.com/watch?v=9VmKkBLkoFQ
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