Senior C&Q/CSV Specialist — Project Lead

Validation & Engineering Group; Puerto Rico; Presencial; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Competitive Compensation

Training opportunities

Excellent job environment

Quality of life

Descripción de la vacante

A leading services supplier in pharmaceuticals is seeking a qualified individual for a full-time position focused on mechanical commissioning and validation in Puerto Rico. The ideal candidate will have a Bachelor’s degree in a relevant field and extensive experience in commission and qualification lifecycles. Candidates should possess strong interpersonal and leadership skills and be fully bilingual. Competitive compensation and a positive work environment are offered.

Formación

• 5-10 years of experience in C&Q Lifecycle, CSV Lifecycle, Equipment/Facilities/Utilities Commissioning.
• Experience with QA Systems and Laboratory Equipment Qualification.
• Fully bilingual.
• Strong initiative and leadership capabilities.

Responsabilidades

• Serve as focal point for mechanical commissioning & qualification (C&Q) and computer system validation (CSV).
• Work on multi-discipline engineering capital project teams.
• Manage project goals within scope, budget, and schedule.
• Measure and report project execution progress.
• Development of C&Q/CSV Strategies.

Conocimientos

Mechanical commissioning

Computer system validation

Project management

Interpersonal skills

Leadership skills

Educación

Bachelor Degree in Science, Engineering, Computer Science, or related discipline

Descripción del empleo

• Full-time

Company Description

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.

Job Description

• 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 havefive 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 availablefor Puerto Rico.

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

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