Validation Engineer

As a global organization, PharmEng Technology has been providing quality services to leading manufacturers of the Pharmaceutical and Biotech industries since 1997. Our employees come from diverse backgrounds where we value unique talents and work together to support our clients. In addition, our consultants have extensive experience obtained from world-class organizations across the globe, and the development of our staff continues to grow PharmEng Technology.

We are seeking an experienced Validation Engineer.

Objectives of this Role:

• Write and execute, Installation Qualification (IQ), and Operational Qualification (OQ) protocols and Summary Reports including thorough resolution of protocol discrepancies.
• Assess potential sources of variation in materials, processes, facilities, equipment, products, and packaging processes that may impact consistent performance or product quality; where needed, design studies to characterize impact of identified sources.
• Maintain an up-to-date knowledge of validation requirements, practices, and procedures.
• Interpret existing Validation Plans and Project Plans and apply concepts to the task at hand.
• Working with a team to ensure all aspects of activity within the Process Development and Validation group adhere to required policies and procedures, including safety and training.
• Investigate/troubleshoot validation problems, as well as, conduct some statistical analysis of testing results.

Skills and Qualifications:

• Bachelor’s degree in engineering, life science discipline, or equivalent experience in the pharma/biotech industries.
• Highly capable of developing, executing, and reviewing validation life cycle protocols.
• Knowledge of validation principles, standard concepts, practices, procedures, and requirements in GMP regulated environments.
• Proven capability to assess processes, equipment, and products for sources of variation, ability to analyze data and reach appropriate conclusions, and to perform and appropriately document deviations and investigations.
• Experience with validation and working knowledge of production is a plus.
• Familiarity with FDA regulatory requirements for the Pharmaceutical/biopharmaceutical industry (i.e. GMP and GLP).
• Experience with Microsoft Office Suite.
• Experience Programing LabView require

PharmEng Technology is committed to attracting and retaining world-class employees valued for their contributions to achieving business objectives. PharmEng offers continuous career growth, competitive wages, travel opportunities, a team mentality that sets us apart from our competitors, and more!