CSV (233244) Hybrid onsite Virginia


Duration: 3 Month Minimum (6-9 is expected duration)

Hours per week: 40

Start Date: June 12th (sooner if possible)

Job Description: Our client is seeking a Computer Systems Validation Specialist to provide support for computer system validation activities, working in compliance with GMP, GAMP, 21 CFR Part 11, ICH Q7, Annex 11, and Data Integrity guidance. The primary focus of this role is computer systems validation and qualification of equipment, including reaction equipment, control equipment, and computer components to delta V. The CSV Specialist will also provide support as needed for maintaining labs and LIMS (Laboratory Information Management System). Additionally, the role involves user administration, security administration, computer system lifecycle maintenance, and assisting users with software/systems issues. The ideal candidate should have a minimum of 8 years of experience in Computer System Validation. They should possess prior experience in writing, reviewing, and executing computer validation documentation, risk assessments, change controls, and SOPs. Familiarity with automated manufacturing and production lines, including PCS and PLCs, are nice to have while experience in lab software, IT infrastructure, and application qualification are requirements.

Skills: CSV, GMP, Regulatory Compliance (21 CFR Part, 11, GAMP 5, ICH Q7, Annex 11, Data Integrity), Process controls, QC Lab equipment

Education: Engineering related degree

CSV (233244) Hybrid onsite Virginia

About Black Diamond Networks
Black Diamond Networks delivers talent uplifted. We deploy highly skilled consultants to support quality, compliance, and innovation in regulated industries and beyond. Black Diamond’s delivery model is wired for speed and precision, due to a cultivated community of experts in life sciences, engineering, and technology. Raise your expectations for dynamic solutions.

Black Diamond Networks is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.

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