C&Q 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. 

Responsibilities:

• Serve as focal point for Facility commissioning & qualification (C&Q) and computer system validation (CSV) in support of the delivery of capital projects.
• Work on multi-discipline engineering capital project teams, as well as other project-related, cross-functional teams with representatives from departments throughout the organization.
• Project management tools, processes, and principles to enable successful project execution.
• Manage assigned project goals within scope, on budget, and on schedule.
• Measure and report project execution progress.
• Decision-making and make influential recommendations regarding best options.
• Validation Life Cycle, Reports and Master Plans.
• Communicate proactively with stakeholders and senior management regarding progress, issues, and plans for resolution.
• Development of C&Q/CSV Strategies.
• Review C&Q/CSV documents prepared by others.
• Develop and execute C&Q/CSV for special projects.

Qualifications Requirements/Knowledge/Education/Skills:

• Bachelor Degree in Science, Engineering, Computer Science, or related discipline.
• Must have five to (5 to7) seven years of experience in o C&Q Lifecycle, CSV Lifecycle, Equipment/Facilities/Utilities Commissioning and Qualification, QA Systems, for the pharmaceutical, biotechnology and medical device industries.
• Develop and execute IOQ with CSV protocol.
• Develop Validation Summary Report. Fully bilingual (Spanish and English). Great interpersonal, initiative and leadership skills.

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 equipment's, 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. The noise level in the work environment is usually moderately loud.