- This role pertains to our Talent Bank.
- 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.
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CSV Specialist - Boston, United States - Mentor Technical Group
Description
Mentor Technical Group (MTG) provides a comprehensive portfolio of technical support and solutions for the FDA-regulated industry. As a world leader in life science engineering and technical solutions, MTG has the knowledge and experience to ensure compliance with pharmaceutical, biotechnology, and medical device safety and efficacy guidelines. With offices in Caguas, PR, Boston, MA & San Francisco, CA and we serve life sciences clients in six global markets: United States, Puerto Rico, Dominican Republic, Mexico, Germany, Canada, and South America.
Job Description:
Requirements/Qualifications:
