Sr. Validation Engineer at TekWissen LLC

Overview: TekWissen is a global workforce management provider headquartered in Ann Arbor Michigan that offers strategic talent solutions to our clients world-wide. Our client is an American multinational information technology services and consulting company and is a leading provider of information technology consulting and business process outsourcing services dedicated helping the worlds leading companies build stronger businesses. Job Title: Sr. Validation Engineer Work Location: Wilson NC 27893 Duration: 12 Months Job Type: Temporary Assignment Work Type: Onsite Job Description: The Senior Validation Engineer will lead and execute commissioning and qualification (C&Q) activities for automation systems at the. This role ensures compliance with GMP regulations and internal quality standards supporting the successful delivery of validation documentation and execution for new and existing systems. Key Responsibilities: Lead and manage C&Q lifecycle activities including URS DQ IQ OQ and PQ for automation and process systems. Collaborate with cross-functional teams including engineering QA manufacturing and automation to ensure validation deliverables align with project timelines. Develop and review validation protocols reports and supporting documentation in compliance with FDA EU standards. Utilize tools such as Kneat GVault or equivalent systems for document control and validation tracking. Provide technical guidance and mentorship to junior validation engineers and contractors. Support change control processes and deviation investigations related to validated systems. Participate in audits and inspections providing subject matter expertise on validation practices and documentation. Ensure alignment with the overall execution and resource plan as outlined in the C&Q strategy. Required Qualifications: Bachelors or Masters degree in Engineering Life Sciences or related field. Minimum 7 years of experience in validation within the pharmaceutical or biotech industry. Strong knowledge of cGMP FDA ICH and EU regulations. Proven experience with commissioning and qualification of automation systems. Proficiency in validation tools such as Kneat GVault or similar platforms. Excellent communication documentation and project coordination skills. Preferred Qualifications: Experience working on large-scale C&Q projects in a regulated environment. Familiarity with systems and validation practices is a plus. PMP or equivalent project management certification. Top 3 must haves: Life science Domain Validation Skills Delta V & MES Validation TekWissen Group is an equal opportunity employer supporting workforce diversity. Key Skills Python,SOC,Debugging,C/C++,FDA Regulations,Minitab,Technical Writing,GAMP,OS Kernels,Perl,cGMP,Manufacturing Employment Type : Full Time Experience: years Vacancy: 1