Job Posting: Computer System Validation (CSV)
Duration: 3 to 6 months, Initial Term
Employment Type: ICQ W2
Location: Greater Baltimore Area
EDUCATION & EXPERIENCE REQUIREMENTS
B.S. degree in Biology, Biochemistry, Chemistry, Engineering or equivalent years’ experience working in FDA-regulated industries.
- Successfully working within a multi-disciplinary team coordinating and delivering project activities meeting schedule, budgetary and quality expectations of the client.
- Customarily and regularly exercises discretionary and independent judgment in performing the job.
- Participate in training to ensure continued accreditation.
- Maintain a safe working environment for self, team members and clients operational or administrative staff.
- Other tasks in alignment with your skills and competencies as required by the project, client and/or management.
- Must have excellent organizational, verbal and written communication skills; with demonstrated ability to efficiently and effectively communicate with cross-functional teams and management on recommended course of action, with minimal assistance.
- Must have proficient computer skills and be experienced using MS Office software (Word, Excel and PowerPoint) and MS Project (as needed).
- Must be a self-starter, detail oriented and able to work independently with minimal supervision.
- Excellent troubleshooting skills; ability to react quickly to understand and solve problems.
- 5 plus years of Commissioning, Qualification and/or Validation (CQV) with experience in Bio-process operations.
- Experience writing protocols, performing execution for processes, equipment and utilities used in the Biotech or Pharmaceutical Industry.
- Direct experience within the following areas; Computer System Validation (CSV), Data Integrity, Standard Operating Procedure (SOP), Change Control, Deviations, Master Validation Plans, Risk Assessments, CAPAs, GMP investigations, Quality Risk Management (QRM), Data Analysis, Process Automation System (PAS), Enterprise System single use technologies.
Please note that only local candidates will be considered.
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