Senior Commissioning & Qualification Specialist

Senior Commissioning & Qualification Specialist

Validation & Engineering Group, Inc. is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, among other services.

• Serve as focal point for mechanical 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.
• 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

• Bachelor Degree in Science, Engineering, Computer Science, or related discipline.
• Must have five to (5 to10) ten years of experience in o C&Q Lifecycle, CSV Lifecycle, Equipment/Facilities/Utilities Commissioning and Qualification, QA Systems, Laboratory Equipment Qualification, for the pharmaceutical, biotechnology and medical device industries.
• Develop and execute IOQ with CSV protocol. Develop Validation Summary Report.
• Fully bilingual
• Great interpersonal, initiative and leadership skills.

Additional information We offer Competitive Compensation, Trainings, Excellent Job Environment and Quality of Life. Validation and Engineering Group is an EEO employer.

Additional Information

Positions available for Puerto Rico.

Validation and Engineering Group, Inc is an Equal Employment Opportunity employer.