TRESUME Looking for Junior CSV Engineer at Ellicott City, MD Full Time

Job 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.
• 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.

Qualifications:

• Master’s Degree in Chemical Engineering, Biomedical Engineering, Computer Science or IT/IS from a 4-year University.
• 3-5 years of CSV experience is required.
• Previous experience in GxP Industries / Life Science Industries is required.
• Must have strong written and verbal communication skills.

Job Types: Full-time, Contract

Pay: $60,000.00 – $80,000.00 per year

Benefits:

• Dental insurance
• Health insurance
• Life insurance
• Professional development assistance
• Referral program
• Vision insurance

Schedule:

• 8 hour shift
• Monday to Friday

Work Location: Multiple Locations