- Master's Degree
- Bachelor's Degree
- Analysis Skills
- Microsoft Office
- FDA Regulations
- Communication Skills
Validation & Engineering Group USA (V&EG USA) provides world-class service and expertise to the Biotechnology, Pharmaceutical, Medical Devices, Chemicals (API), Food, and Cosmetics industries. For over twenty years, V&EG has placed the most talented individuals in a position to make a difference in our customer’s success. Our services platform is split into four distinct areas: Regulatory Compliance, Validation and Qualification, Laboratory (Validation, Audits), and Engineering (Design Qualification Services), that ensure adherence to Federal and European regulatory agencies.
Participate in a variety of Validation Life Cycle activities including, but not limited to:
Manufacturing and Packaging Equipment Commissioning/Qualification activities.
Process Validations, Cleaning Validation, and Computer System Validation (CSV) activities.
Utilities and Facilities Commissioning/Qualification activities.
Preparation and/or execution of SOP’s, IQ/OQ/PQ, Investigations and CAPA.
Work side by side with other team members to develop validation knowledge and skills within the industry.
Able to directly work in production/packaging environments.
Able to work in construction environments.
Follow internal procedures and external standards.
Bachelor's and/or Master's degree in Engineering or Sciences fields from an accredited University.
3-5 years of experience in the pharmaceutical industry.
Proficient using MS Windows and Microsoft Office applications.
Willing to travel 75% or more within and outside USA.
Available to work administrative and rotated shifts, holidays and weekends, if required.
Knowledge in FDA Regulations, cGMPs and ISO guidance (preferable, but not required).
Self-starter with excellent technical writing, analytical and communication skills.
Detail oriented and team builder.
Strong Abilities: People skills, Leadership, Commitment, Trust, Excellence, Honesty, Innovation, Loyalty, Respect & Teamwork.
Positions available for Puerto Rico.
Validation and Engineering Group, Inc. is an Equal Employment Opportunity employer.