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Posted: Thursday, March 9, 2017 6:24 PM

Job Description:/h3:
Azzur Group CA is looking for a Validation Engineer to join our growing Southern California team. In this role, you will be responsible for the startup, commissioning and qualification of various facilities, utilities and process/equipment systems. Examples of equipment include, but not limited to: CIP Skids, WFI systems, Pure Steam, Compressed Gases, Autoclaves, Glass Washers, Bioreactors, Mixing Tanks, Centrifuge, AHU System and CTUs (controlled temperature units; IE fridge, freezer). Startup responsibilities include coordinating vendor SAT support, system troubleshooting, commissioning and operational qualification of equipment.

Essential Duties and Responsibilities

Performs/executes/validation/verification studies (FAT, SAT, IQ, OQ, PQ) for cleaning, shipping, equipment, systems, utilities, and processes for
qualification/verification and/or re:qualification/re:verification.
Writes, and executes protocols, reviews and analyzes study data, writes summary reports.
Writes, reviews and revises a variety of installation, operation and performance qualification/ verification related documents.
Writes reports to summarize
validation/verification/commissioning and/or re:validation/
verification/commissioning activities.
Reviews, advises on and contributes to change control documents. Provides sound validation/ verification assessments.
Provides guidance and input to facilitate technical transfers and contract manufacturing.
Provides technical assistance to others when required.
Supports the resolution of regulatory observations or manufacturing site issues.

Qualifications
BS in Engineering, Science or equivalent technical degree.
2+ years Validation Engineer experience in validation services 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.

Azzur Core Values:
Puts Others First...Have the Courage to Take Action...Take Personal Responsibilities...Have Fun
Company Description:/h3:
Azzur Group is a growing private company offering GxP compliance consulting and staffing services dedicated to helping life sciences companies succeed. Our experienced staff specializes in manufacturing systems and equipment design, installation and startup, commissioning, and verification/qualification, computerized systems validation, and process validation. Azzur also offers GxP compliance and audit services related to regulatory inspection prep and inspectional finding remediation as well as general project management support. We are continuously updating and maintaining our knowledge base with the latest regulatory requirements, industry best practices, and inspectional trends to help our clients stay ahead.

Source: https://www.tiptopjob.com/jobs/64419514_job.asp?source=backpage


• Location: Los Angeles

• Post ID: 104036718 losangeles
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