Lab Validation Engineer

NOT OPEN FOR C2C CONTRACTSWe are a service provider company, leader in the Pharmaceutical and Medical Device sectors since 1998, with more than 1500 employees, 45+ nationalities and 28 subsidiaries all over the world (Europe, Asia and the Americas). Joining PQE means being a part of a multicultural and challenging company, with many local and international projects, and colleagues from all over the world.Due to a constant growth, PQE is looking for a Senior Lab Validation Engineer based in Zebulon, North Carolina. This contract is for 2 years working on a hybrid schedule with the site.Responsibilities include, but are not limited, to the followings:Manage the development and implementation of business or scientific systems in the QC Department.Develop, monitor and track projects with regards to schedule, quality and performance with regular updates to all levels of management.Act as decision point for issues which span departments.Obtain and define customer requirements to establish plans and activities necessary to meet objectives and maintain change controls in the areas of project scope and direction.Assist in controlling capital and expense items related to the Project by assuring the proper cost tracking mechanisms are in place.Provide technical support and leadership pertaining to analytical/microbiological testing. Verify that results are accurate and complete, recognize deviations in analytical test procedures and SOPs, evaluate product trends and perform QC testing when necessary.Notify & participate with management and interdepartmental teams concerning expanded investigations (external to the laboratory).Serve as site representative for specialized technology in interdepartmental and international project teams (e.g. new product development, CAPs, USP).Lead and encourage continuous improvement within QC.Participate in internal and external audits (cGMP and FDA). Ensure compliance to regulated procedures.Provide input into the development of analytical/microbiological methods, specifications, testing protocols, SOPs and regulatory documents (NDAs, sundaes, MAAs, etc.) and act as ongoing SME for troubleshooting of methods and instrumentation.Requirements:Bachelor''s Degree + 4 years'' relevant pharmaceutical experienceDemonstrated ability to participate in project managementUnderstanding of ICH guidance (ICHQ), GMP requirements and FDA/EMEA regulations.Good understanding of products, data and/or statistical tools, to be able to discuss and understand the state of the laboratory in relation to business metricsProficiency with computers and laboratory instrumentation preferredLocation: Zebulon, North CarolinaOur collaborators are engaged, developed, challenged and well-rewarded for performance. We recognize the importance of leadership at all levels of our organization in order to succeed in a challenging business environment, and we are committed to providing practical processes and programs to identify, develop and inspire all our current and future leaders.

Created: 2025-11-15