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Katalyst Healthcares & Life Sciences
Libertyville, IL | Contractor
$102k-118k (estimate)
5 Months Ago
MENTOR TECHNICAL GROUP is Hiring a CSV Specialist Near Boston, MA
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:
Mentor Technical Group is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
Job Description:
- 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.
Mentor Technical Group is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
Job Summary
JOB TYPE
Full Time
SALARY
$101k-120k (estimate)
POST DATE
05/28/2024
EXPIRATION DATE
06/15/2024
WEBSITE
mentortg.com
HEADQUARTERS
PR
SIZE
200 - 500
FOUNDED
2000
CEO
LUIS DAVID SOTO
REVENUE
$10M - $50M
INDUSTRY
Scientific Services
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The following is the career advancement route for CSV Specialist positions, which can be used as a reference in future career path planning. As a CSV Specialist, it can be promoted into senior positions as a Validation Engineer IV that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary CSV Specialist. You can explore the career advancement for a CSV Specialist below and select your interested title to get hiring information.
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