PSC Biotech is a leading process consulting and contract engineering company. For over 19 years we have been engaged in providing laboratory support, project, process, engineering and validation support to top-tier pharmaceutical and biotech companies.
We are looking for an Entry-Level Computer System Validation Engineer to support our client in Irvine, CA. This role would work alongside an amazingly talented PSC Team, and works under the leadership of one of the best in the industry!
Successful candidates will have excellent verbal and written communication skills, an understanding of the IT realm, and a thirst to learn!
Provide CSV authoring, review and approval of validation documents developed by functional validation teams, ensuring the documentation meets regulatory requirements and quality standards.
Initiate/update GxP and Risk Assessments on system.
Author, Review and or approve scheduled periodic reviews.
Author, Initiate, and/or review and approve IT SOPs related to compliance
Collaborate with project stakeholders and the information systems team to define needs and achievable solutions and/or justifications to system requirements
Draft and execute computer system validation documentation
Validation Project Plan
Requirement Specification (URS, DS, FS)
IQ and OQ Test Scripts
IQ/OQ/PQ Protocols, as necessary
Traceability Matrix (TMX)
System Release Memo
Validation Summary Report
Translate system requirement specifications into executable validation protocols
Provide support to executors of the protocols when needed
Write reports summarizing system validation
Bachelors Degree in Chemical or Biomedical Engineering from a 4 year University
Must have strong written and verbal communication skills
Previous experience in IT Industry is preferred
Previous experience in GxP Industries are preferred
Must be adaptable, customer service oriented, have a positive attitude
This role requires additional hours worked. You must have a flexible schedule