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Senior Validation Engineer

3 months ago

Concord, North Carolina, United States Performance Validation Full time

Performance Validation, Inc has provided Commissioning, Qualification and Validation services to the life science industries for over 35 years. PV is a 100% employee-owned company with teams in Indiana, Michigan, Illinois, Kansas and North Carolina providing support throughout the US and overseas. PV is committed to providing growth opportunities to its employees through professional development, implementation of new services and cultivation of new geographical areas. Additional information on Performance Validation is available at

Performance Validation is seeking a full-time Sr. Validation Engineers/Specialist to join our North Carolina team. The Sr. Validation Engineer/Specialist reports directly to the Division Director and will be assigned to the project team in Concord, NC.

Expectations:

Performance Validation is seeking a Sr. Validation Engineer/Specialist with 5-7 years experience to demonstrate a sound knowledge, application and proper implementation of technical, quality and scientific principals necessary to meet industry and customer requirements. This individual is expected to work in a team environment or independently to meet defined objectives based on an established timelines and deliver project work in a manner that is consistent with the companys values. The activities would include:

Development of Verification/Qualification deliverables including but not limited to Requirements Documents, Functional and Design Specifications, Test Protocols (IQ/OQ/PQ), and Summary Reports.

Execution of Test Protocols, including identification and resolution of non-conformances/deviations.

Tracking and managing change control activities for multiple concurrent projects.

Minimum Qualifications

A Bachelors degree in Engineering, Life Sciences, or other related technical field (or equivalent military training) with six or more years of experience in pharmaceutical or other regulated industry.

Experience

Experience with any of the following: Process Equipment, filling or packaging equipment, lyophilzation, thermal mapping, critical utilities (Nitrogen, Compressed Air, Clean Steam, HVAC Validation, Compendia Water Systems), sterilization/depyrogenation, cleaning validation planning and execution, fermentation/bioreactors, PLC/DCS Systems, P&ID Development.

Skills

The candidate must:

  • Have excellent writing skills.
  • Be a self-starter and be motivated to provide a solid product quality and customer experience.
  • Possess effective skills for developing, performing, evaluating, troubleshooting for operating systems and controls, or within a specific scientific / technical discipline.
  • Well-developed knowledge of pharmaceutical industry standards and requirements (e.g. cGMPs, GAMP, ICH, ISPE baseline guide, ASTM E2500).

Qualified candidates must be legally authorized to be employed in the United States. PV does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position.