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Computer System Validation Engineer

PSC Biotech Petaluma ,CA
  • Expired: 20 days ago. Applications are no longer accepted.
Job Description

Foundedin 1996, PSC Biotech Corporation was created with the vision of providing lifescience companies with services designed to help achieve regulatory compliancerequirements. PSC Biotech Corporation serves over 350 clients in more than 23 countriesthrough professional services consulting, cloud-based software solutions, andpharmaceuticals contract manufacturing. PSC Biotech Corporation has threeunique active divisions within the parent company, each representing one of ourareas of expertise: PSC Biotech™, PSC Software™, and BioTechnique™. Together,these divisions enable us to meet the ever-changing needs of our clients with acommitment to excellence and superior quality.

 

We are seeking Computer System Validation Engineers with experiencedeveloping master plans, authoring/executing protocols, analyzing test results,and preparing technical reports.

Responsibilities:

  • WriteValidation Protocols such as IQ, OQ and PQs
  • ExecuteValidation Protocols such as IQ, OQ and PQs to ensure compliance and adherencewith applicable guidelines.
  • ExcelSpreadsheet Generation and Summary Report Writing for PQ studies.
  • Reviewand modify Standard Operating Procedures (SOPs)
  • Generatetest procedures to validate new or previously invalidated processes
  • Writerisks assessments and applicable test scripts according to GLP and 21 CFR Part11 compliance guidelines and the Validation Master Plan.
  • Preparevalidation summary reports for executed protocols.
  • IXRS/Clinical Experience strongly preferred
  • CommunicateComputer System Validation approaches and requirements during planning/audits.


Requirements
  • MinimumBachelor's degree in Engineering (Chemical, Biomedical, Mechanical, etc.),Computer Sciences, or Life Science major (Biochemistry, Chemistry, Pharmacy,etc.)
  • 1+years in Computer System Validation with strong pharmaceutical / biotechindustry experience.
  • IXRS/ClinicalExperience strongly preferred.
  • Experiencewith 21 CFR Part 11 regulation/ EU regulations required.
  • Interestedin making a contribution to the company while learning
  • Interestedin learning validation and other activities required for companies to becompliant with Food and Drug Administration (FDA) regulations
  • Strongcommunication and interpersonal skills.

#PSC


PSC Biotech

Address

Petaluma, CA
USA