ATL01-110221 Entry Level Validation Engineer/Specialist

Company Description

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.

Job Description

• 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,
  • Review of drawings, TOP packages and validation life cycle documentation.
• 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.

Qualifications

• Bachelor's and/or Master's degree in Engineering or Natural Sciences from an accredited University.
• 0-5 years of experience in the pharmaceutical industry.
• Proficient using MS Windows and Microsoft Office applications.
• Willing to travel 75% or more within USA.
• Available to work administrative and rotated shifts, holidays and weekends, if required.
• Knowledge in FDA Regulations, cGMPs, Validations 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.