Computer System Validation Professional (Level 1: Entry-Level)
Founded in 1996, PSC Biotech Corporation was created with the vision of providing life science companies with services designed to help achieve regulatory compliance requirements. PSC Biotech Corporation serves over 350 clients in more than 23 countries through professional services consulting, cloud-based software solutions, and pharmaceuticals contract manufacturing. PSC Biotech Corporation has three unique active divisions within the parent company, each representing one of our areas of expertise: PSC Biotech™, PSC Software™, and BioTechnique. Together, these divisions enable us to meet the ever-changing needs of our clients with a commitment to excellence and superior quality.
We are looking for an Entry-Level Computer System Validation Professional. 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!
Responsibilities:
- 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
Requirements:
- Bachelors Degree in Chemical Engineering, Biomedical Engineering, Computer Science or IT/IS 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
- No C2C/ No Sponsorship