Job Posting: Computer System Validation (CSV)
Duration: 6 months to 1 year
Location: Greater Baltimore Area
B.S. degree in Biology, Biochemistry, Chemistry, Engineering or equivalent years’ experience working in FDA-regulated industries.
- Assist in authoring and revising procedural controls, assessment forms or checklists, associated process work instructions, and potential ERES training materials.
- Implement and support 21 CFR Part 11 & EudraLex Annex 11 assessments on electronic systems, components, module, instruments, and equipment as used in a GxP environment.
- Perform gap analyses as required based on these assessments.
- Prepare reports, strategies, and recommendations for required remediation and risk mitigation for these gaps.
- Develop new standard operating procedures (SOP) or modify existing SOPs as appropriate as a part of the approved remediation strategy. These might include but would not be limited to: audit trail initiation and maintenance, system and data backup & recovery, disaster recovery, and any associated Administrative or User SOPs.
- Assist system owners and technical managers in developing remediation and risk mitigation technical controls to fulfill asset ERES requirements when and where feasible.
- Coordinate with the quality assurance and validation Core Team to maintain the defined and approved remediation and mitigation strategy.
- Managing multi-site documentation alignment teams under the approved strategy.
- Manage validation and qualification support staff in their efforts in for this strategy.
- Coordination of remediation and mitigation validation activities and deliverables (risk analyses, testing protocols, etc.) against an agreed strategy.
- Ability to detect possible ERES compliance issues in advance and to define potential ad hoc mitigation actions per time, in collaboration with Core Team
- Deliverables creation (e.g. presentation, reports, project/validation documentation) as necessary.
- Support staff activity planning, e.g. documentation amendment, progress reporting, training.
- Provide advisory services to senior quality assurance and validation management on ERES issues as they arise.
- 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.
- 10+ years of Commissioning, Qualification and/or Validation (CQV) with experience in Bio-process operations.
- Solid familiarity with GxP regulations and relevant records management
- Thorough understanding of associated regulatory compliance literature and guidelines, including GAMP5, ASTM E2500, ISO, etc.
- Significant expertise with application of 21 CFR Part 11 and EudraLex Annex 11 (ERES) requirements, and identification of compliance gaps and preparation of mitigation strategies.
- Developed and implemented ERES compliance gap remediation for GxP-covered systems, components, modules, instruments and equipment.
- In-depth understanding of all computer system lifecycle deliverables based on approved Commissioning & Qualification (C&Q) and Computer System Validation (CSV) processes.
- Experience in developing various procedural controls, formal work instructions, job aids, and other related documents.
- Knowledge in controlled documentation approval life-cycle and good documentation practices (GDP).
- Superior written and verbal English communications skills.
- Expertise in advanced MS-Office applications (Word, Excel, Project, PowerPoint, Visio, and Skype).
- Demonstrated ability to work extended hours under stressful conditions, while inspiring team members to achieve common goals.
Please note only local candidates will be considered.
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