Computer System Validation Engineer

PSC Biotech Corp.

Athens, CA

Expired: over a month ago Applications are no longer accepted.

Contractor

Job Description

PSC is a leading life sciences consulting and IT services company. For over 19 years we have been engaged in providing project, process, IT, engineering and validation support to top-tier pharmaceutical and biotech companies.

PSC is seeking for experienced Computerized System Validation Engineers with background in validation of computerized systems of manufacturing equipment, utilities, and facilities to support our client in GA.

Responsibilities:

Contribute to a team focused on computerized system validation efforts throughout a commissioning project
Write computerized systems validation protocols such as IQ, OQ and PQs for manufacturing equipment, facilities, and utilities systems.
Generate test procedures to validate new or previously validated processes
Traceability matrix generation
Execute validation protocols to ensure compliance and adherence with applicable guidelines
Summary report writing/reviews for qualification studies
Discrepancy/deviation document development (as needed)

Requirements:

Experience with Process Control Systems
Minimum Bachelor's degree in Engineering (Chemical, Biomedical, Mechanical, etc.), Computer Sciences, or Life Science major (Biochemistry, Chemistry, Pharmacy, etc.)
3+ years experience in computerized system validation within the pharmaceutical/biotech industry
Experience with Good Documentation Practices
Experience with 21 CFR Part 11 regulation/ EU regulations required.
Superb communication and interpersonal skills
No C2C / No Third Party Resumes / No sponsorship

Company Description

PSC Biotech Corporation is a global, employee owned, life sciences consultancy that performs projects and staff augmentation in the following disciplines: Engineering, Information Technology, Technical Services, Validation, Compliance, Regulatory Submissions, Clinical, Project Management and Quality Assurance. PSC Biotech, incorporated in 1996, has been performing projects globally for over 20 years.