Title: TraceLink EU Computer Systems Validation Engineer
Type of role: Contract (Remote)
Client location: South San Francisco
Contract length: 6+ months
The Computer System Validation (CSV) Analyst is responsible for TraceLink system validation activities and ensuring computer systems follow applicable EMEA/EU Annex 11 regulations. Knowledge of EU GTIN needed.
This role is also responsible for the development of Standard Operating Procedures (SOPs) and templates specifically related to software validation and testing. Duties include executing the validation of new systems; ensuring / verifying compliance with appropriate regulations and maintaining required change control procedures. The CSV Analyst will develop design and test documentation including user requirements, risk assessments (RA), test plans, Design Qualification, Installation Qualification, Operational Qualification and Performance Qualification (DQ/IQ/OQ/PQ) tests and validation summary reports.
- 6+ years of experience in the Pharmaceutical or Biotech industry
- Recent experience validating TraceLink
- Must have profound knowledgeable of EMEA/EU, International related regulations and FDA guidelines such as GAMP and ICH and ISO. Specific knowledge of computer validation methodologies and principles is a must.
- Knowledge of CSV requirements and procedures (IQ/OQ/PQ) for on-premise and SaaS solutions.
- Strong experience with performing change controls, drafting UAT’s and performing risk assessments.
- Working, hands-on, knowledge of the development of protocols for the validation of complex computer systems (e.g., multiple GAMP classes of systems).
- Strong organizational, communication (written and oral), and interpersonal skills. Team oriented, dependable, self-starter.
- Ability to work independently, attention to detail, maintain accurate records, follow instructions, and comply with company policies.