CSV Specialist
Mentor Technical Group
- Humacao, PR
- Permanent
- Full-time
- Responsible for the development and execution of Computer System Validation (CSV) and Decommissioning deliverables for Laboratory Equipment/Systems.
- Acts as the on-site project leader to plan, execute, and complete control systems projects with assigned client sponsor.
- Performs or delegates tasks as required to execute and fully complete assigned projects.
- Coordinates communication with the client sponsor during all phases of the project.
- Provides work direction to team members, and administration, as necessary.
- Ensures work performed is in compliance with company policy and procedures, and regulations.
- Lab Equipment/systems may include GMP equipment’s such as: (KFT (Coulometric), FT-NIR, LIF, NIR, Homogenizer, Spectrophotometer, DQAS, Accelerated Surface Area and Porosimetry System, KFT (Volumetric), FTIR, Titrator (Potentiometric), TPW, Freezers, Refrigerators).
- Bachelor’ s degree or higher in Chemistry/Biology/Microbiology/Computer Science/Information Systems/Engineering or related discipline.
- Minimum of eight (8) years of experience validating laboratory computerized systems in a manufacturing environment is required.
- Knowledge of SDLC regulations, including 21CFR part 11, computer systems validation requirements.
- Must have experience in configuring computerized systems with complex vendor software systems, and windows operating systems.
- Must have experience drafting and executing test plans intended to show system compliance with part 11, including items like, user access levels, audit trails, backup, restore, etc.
- Knowledge of cGMP, GXP, GAMP, and good documentation practices.
- Advanced knowledge of pharmaceutical, manufacturing and laboratory systems.
- Understanding of investigations, deviations and CAPA management in a regulated pharmaceutical industry.
- Strong written and verbal communication skills.
- Excellent interpersonal skills with experience dealing with a diverse workforce.
- Strong multi‐tasking ability in conjunction with proven organizational skills. Ability to organize assigned tasks in a high paced environment and concurrently monitor tasks / assignments with others that may impact timely completion. Ability to effectively manage multiple tasks and activities simultaneously.
- Highly proficient computer skills in Microsoft Office Suite – Word, Excel, PowerPoint and Outlook with extensive background in database systems. Innate ability to learn new software, such as corporate intranet and enterprise business.
- Experience authoring, owning and executing qualification documentation.