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Validation Specialist
$76k-95k (estimate)
Full Time
1 Week Ago
MENTOR TECHNICAL GROUP is Hiring a Validation Specialist Near Cambridge, 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.
Essential Functions:
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.
Essential Functions:
- Asset/system decommissioning and documentation lifecycle closeout.
- Asset Decommissioning
- Mechanical Equipment
- System
- Equipment Decommissioning
- CSV Retirement.
- Perform activities related with Validations according to project assignment, customers' needs and requirements and in compliance with cGMP's and Safety procedures
- Investigate client's customer complaints, issues, applicable reports indicating possible cause, and recommend solutions.
- Write/revise/execute Commissioning/Qualification/Validation documents, as applicable, following established standards and templates, including:
- Commissioning Forms
- C/Q/V Protocols and Summary Reports
- Standard Operating Procedures
- Impact/Risk Assessments
- Specifications (URS/FRS/DS)
- Electronic Records/ Electronic Signature (ERES)
- Data Integrity
- Coordinate execution activities as required by commissioning, qualification, validation protocols.
- Provide support to the vendor's installation and commissioning, qualification, validation activities.
- Exhibit a customer-oriented behavior, by clearly understanding customers' needs and expectations, and anticipating possible barriers or obstacles that may impact the project(s) adversely and communicating these on a timely manner.
- Provide support in projects related to process optimization, trouble-shooting, new products and validation of facilities, utilities, and equipment qualification, therefore, responsible for the quality of the product provided to client customers.
- Provide documentation free of errors, controlled and well-organized. (Right the first time)
- Design backup, restoration, archive, and disaster recovery strategy procedures for computer failures.
- Manage technical issues/problems appropriately and efficiently.
- Promote excellent relationship with MENTOR clients, encouraging an open dialog and trustful communication between both parties demonstrating a professional conduct always and proudly represent MENTOR at all levels and places.
- Other responsibilities as assigned by supervisor/management, and/or client.
- Complies with MENTOR's administrative requirements timely and consistently in areas such as: weekly reports, updating of CV's, yearly updates of medical/training records, attendance to work, etc.
- Bachelor's in Engineering, Pharmacy or Science related fields, as a minimum.
- Formal education and training on Equipment/System validation concepts and life cycle.
- Hands-on experience in the development and/or review of decommissioning life cycle documentation and reports.
- Hands-on experience in CQV protocols execution. Tested skills developing Technical Reports.
- Minimum five (5) to eight (8) years of working experience in a pharmaceutical production environment.
- Good interpersonal skills with an assertive and pro-active approach towards work.
- Excellent communication skills (English and Spanish).
- While performing the duties of this job, the employee is regularly required to use hands to finger, handle, feel, or operate equipments, tools, or controls. The employee frequently is required to stand, walk, talk, or hear; sit; climb or balance, stoop, kneel, crouch or crawl; and smell. The employee may lift and/or move up to 25-35 pounds and occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, depth perception, and the ability to adjust focus. He / she may frequently work inside weather conditions, near moving mechanical parts, exposed to wet and or humid conditions, and an odorous atmosphere, may be exposed to fumes and the risk of electrical shock, and occasionally work on ladders in high places, in small spaces, such as lift/metering stations, manholes, tanks and wet wells.
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
$76k-95k (estimate)
POST DATE
05/07/2024
EXPIRATION DATE
05/20/2024
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 Validation Specialist positions, which can be used as a reference in future career path planning. As a Validation Specialist, it can be promoted into senior positions as a Validation Engineer II that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary Validation Specialist. You can explore the career advancement for a Validation Specialist below and select your interested title to get hiring information.
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