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Computer System Validation I

Bachem is a listed technology-based company focused on peptide chemistry. The company provides a full range of services to the pharma and biotech industries. It specializes in the development of innovative, efficient manufacturing processes and the reliable production of peptide-based active pharmaceutical ingredients. A comprehensive catalog of biochemicals and exclusive custom syntheses for research labs complete the service portfolio. Headquartered in Switzerland with subsidiaries in Europe, the US and Asia, the group has a global reach with more experience and know-how than any other company in the industry. Towards its customers, Bachem shows total commitment to quality, innovation and partnership.

Your Responsibilities

The QA Computer System Validation Engineer will be required to have a thorough understanding of

industry standards and best practices for computer system validation and lend this expertise to make the

company compliant.

 

Your Tasks

·         Ensure compliance of relevant computer systems and applications with regulatory requirements and controls associated with CFR 21 Part 11 and

          EU GMP Annex 11

·         Development and maintenance of life cycle documents necessary to address the validation lifecycle (Risk assessments, validation plan, SOP,

          etc.)

·         Work directly with local and Central QA departments

·         Participate in  site Projects and manage all activities in regards to validation and qualification of computer systems and applications

·         Represent CSV implementation during regulatory inspections and partner audits and provide CSV related responses to inspectors/auditors

 

Your Profile

 

·         Bachelor’s Degree in Computer Science or Science with 5 years’ experience

·         Proven track record in validation and qualification of complex computer systems

·         Thorough knowledge of cGMP regulations related to CSV including CFR 21 Part 11, EU GMP Annex 11, GAMP, and data integrity standards

·         Experience with writing, reviewing and executing computer validation documentation (Validation plan, IQ, OQ, DQ, SOP, Specifications, Risk

          assessments)

·         Excellent written and oral communication skills

·         Excellent computer knowledge, including Microsoft Word, Excel and PowerPoint

·         Ability to effectively organize, multitask, and work in a fast-paced, deadline driven work environment

·         Ability to communicate in a proactive and solution-focused manner, including keeping management aware of potential issues

·         Detail oriented with the ability to troubleshoot and resolve problems

·         Ability to work independently and manage one’s time

·         Communicate effectively and ability to function well in a team environment

 

Preferred:

·         Experience with CSV in regards to new technologies (e.g. virtualization and cloud (SaaS)

 

 

We Offer

You will be part of a motivated team overseeing the entire development cycle of respective APIs. If you are looking for a new challenge and want to join a motivated team in an internationally renowned company, you should seize this opportunity.


Nearest Major Market: San Diego

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