CSV Specialist

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:

• Asset/system decommissioning and documentation lifecycle closeout.
• Asset Decommissioning
• Mechanical Equipment
• System
• Equipment Decommissioning
• CSV Retirement.

Responsibilities:

•  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.

Qualifications Requirements/Knowledge/Education/Skills:

• 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).

Physical Requirements and Working Environment: 

• 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.