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, 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.
Utilize 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.
Make influential recommendations regarding best options.
Develop validation life cycle reports and master plans.
Communicate proactively with stakeholders and senior management regarding progress, issues, and plans for resolution.
Develop 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.
Five to seven years of experience in C&Q Lifecycle, CSV Lifecycle, Equipment/Facilities/Utilities Commissioning and Qualification, QA Systems, for the pharmaceutical, biotechnology, and medical device industries.
Ability to develop and execute IOQ with CSV protocol.
Experience in developing Validation Summary Reports.
Fully bilingual (Spanish and English) with great interpersonal, initiative, and leadership skills.
Physical Requirements and Working Environment:

Regularly required to use hands to finger, handle, feel, or operate equipment, tools, or controls.
Frequently required to stand, walk, talk, or hear; sit; climb or balance; stoop, kneel, crouch, or crawl; and smell.
May lift and/or move up to 25-35 pounds and occasionally lift and/or move up to 50 pounds.
Specific vision abilities include close vision, distance vision, color vision, depth perception, and the ability to adjust focus.
May frequently work inside in various weather conditions, near moving mechanical parts, and be exposed to wet and/or humid conditions, fumes, electrical shock risks, 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.
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.
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