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:

•  Commissioning Forms
•  C/Q/V Protocols and Summary Reports
•  Standard Operating Procedures
• Impact/Risk Assessments
•  Ensure that all chemicals are properly managed, from the moment a new chemical is requested for purchases or manufacture, by establishing, implementing, and maintaining a chemical substances management program. Perform qualitative risk assessments to risk rank SEG exposures.
• Perform decommissioning activities and final reports for equipment, systems, utilities, facilities and/or manufacturing/packaging process for pharmaceutical, biotech and medical devices industries in accordance with cGMP requirements. Documents include, but not limited to: Commissioning Forms C/Q/V Protocols and Summary Reports Standard Operating Procedures Impact/Risk Assessments Specifications (URS/FRS/DS).

Qualifications Requirements/Knowledge/Education/Skills:

• BS / BA in Engineering, Pharmacy or Science related fields as a minimum
• 3-5 years of experience. 

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. The noise level in the work environment is usually moderately loud.