Validation Engineer (AMLN-02238)

Amylin Pharmaceuticals is committed to improving the lives of people with diabetes and other metabolic diseases through the discovery, development, and commercialization of innovative, cost-effective medicines. Our rapid growth has created the following outstanding opportunity in San Diego, CA:

 

Validation Engineer

 (AMLN-02238)

 

The successful candidate will be relied on to perform the validation of computerized systems and software.

 

Responsibilities:Maintains all documentation pertaining to qualification and validation. Generates software and/or computerized systems validation plans. Develops/reviews software and/or computerized systems requirements and specifications. Generates a variety of validation protocols (IQ, OQ, PQ); examples of some protocols: Waters Empower, EDMS, plate reader, UV/Vis, WinNonlin, Windows servers, etc. Coordinates the proper approval of plans, requirements and protocols. Performs validation protocol execution. Reviews completed protocols for completeness, cGxP compliance and data acceptability. Prepares validation summary and final reports. Supports the Amylin Quality department in any regulatory inspections or audits. Supports Amylin change control, configuration management systems and re-validation events. Documents deviations, system failures and corrective action. Reviews change requests to evaluate validation impact. Coordinates validation execution between all involved departments.

 

Requirements: Bachelor?s degree or equivalent from an accredited university in Engineering, Life Science, Computer Science or a technical discipline. 2-3 years of validation experience or related experience and/or training. 3-5 years of working experience in pharmaceutical, biotech or related industries is preferred. Laboratory systems validation experience is preferred.Knowledge of cGLPs, cGCPs, cGMPs, validation principles, and change control.Ability to follow-up and resolve reviewers? comments, deviations and technical issues.Ability to plan and schedule validation projects. Ability to interface and communicate with multiple groups. Ability to work independently and follow stringent timelines.Proficiency in the use of Microsoft Word, Excel, Outlook and Project.

 

Amylin offers competitive compensation, benefits and stock options. Amylin maintains a drug and alcohol free workplace and all offers of employment are contingent upon satisfactory completion of a pre-employment drug and alcohol test. Please apply online at: http://careers.amylin.com   AA/EEO Employer.

 

Amylin

Pharmaceuticals