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

We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:

• Engineering Compliance Administrator

Job description:

Accountable for managing all engineering & maintenance quality assurance activities for products manufactured, packaged or tested at local operations, deviations management and change control. Promotes and ensures compliance with applicable site requirements, KPIs, cGMP regulations, and other applicable regulations. Demonstrates proficiency and thorough knowledge of statistical techniques, SPC, six sigma concepts and tools, and area policies and procedures. Maintains a current and thorough working knowledge of cGMP requirements for pharmaceutical manufacturing, packaging, laboratory and validation activities.

Responsibilities:

• Ensure compliance of the local operations with the standards of the site and any applicable regulations.
• Lead the engineering and maintenance deviations, compliance, change controls, among others
• Ensure that the engineering and maintenance deviations, compliances, change controls, among others are completed on time
• Execute effectiveness checks
• Develop root cause analysis as part of the investigation process
• Perform statistical evaluations of process data and drive process quality improvement efforts using appropriate statistical and six-sigma tools and techniques
• Support product transfers and/or launches as per business requirements.
• Manage multiple priorities, follow schedules and meet deadlines.
• Keep training record up-to-date.
• Maintain and increase knowledge on standards and local procedures requirements
• Ensure KPIs compliance
• Participate as an active member on project and product teams
• Participate on trainings focused on the described areas (local and external trainings).
• Participate in designing and impact evaluation of changes being proposed.

• Project Manager

Qualifications:

• Bachelor's Degree in Science or Engineering.
• Minimum of 5 years of experience in direct pharmaceutical, medical device or biotechnology industries.
• Experience in direct process / manufacturing areas.
• Must be fully bilingual (English / Spanish) with excellent oral skills.
• Must be proficient using MS Windows and Microsoft Office applications.
• Strong knowledge in cGxP and regulatory guidance as well as understanding of how they are applied to regulatory compliance.
• Technical Writing skills and investigations processes.
• Available to work extended hours, possibility of weekends and holidays.