PharmEng Technology is currently seeking a Validation Specialist for a project in Raleigh-Durham, NC.
- 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.
- Bachelor’s degree in a science / engineering field.
- Highly capable of developing, executing and reviewing validation lifecycle 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.
- knowledge of mixing, filling, filtration and sterilization process as it relates to FDA manufacturing.
- Knowledge of USP, EP, JP and FDA requirements.
- Proven track-record of leading teams and project management experience is highly desired.
- Familiarity with applicable US and worldwide regulatory requirements for the Pharmaceutical/biopharmaceutical industry (i.e. GMP and GLP).
- Experience with Microsoft Office Suite.
- Candidates with 3-5 years of experience are preferred.
- Candidates with validation experience with any of the following: Bench Top Analytical equipment, Autoclaves or Processing Equipment is preferred.