Lead Validation Engineer Architect Wilson, NCFloga Technologies • Wilson, North Carolina, USA
Lead Validation Engineer Architect Wilson, NC
Floga Technologies • Wilson, North Carolina, USA
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job_description.job_card.job_descriptionLead the planning execution and documentation of C&Q lifecycle activities (URS DQ IQ OQ PQ) for automation and process systems . Develop and implement validation strategies in alignment with quality standards and global regulatory requirements Serve as the primary point of contact for validation-related matters across engineering QA manufacturing and automation teams Review and approve validation protocols reports and supporting documentation Manage validation timelines resource allocation and risk mitigation plans Provide technical leadership and mentorship to validation engineers and contractors Support audits and inspections by presenting validation documentation and processes Ensure compliance with cGMP FDA EU and internal quality standards . Experience with large-scale C&Q projects in regulated environments PMP or equivalent project management certification Prior experience leading validation efforts in greenfield or brownfield project s Bachelors or Masters degree in Engineering Life Sciences or related field. 10 years of experience in validation within the pharmaceutical or biotech industry. Demonstrated leadership in managing C&Q projects and teams . Deep understanding of regulatory requirements and industry best practices . Proficiency with validation tools such as Kneat GVault or equivalent. Strong communication organizational and stakeholder management skills.
Role : Lead Validation Engineer / Architect
Location : Wilson NC Onsite
Duration : Long term
Top 3 Must Haves : Life science Domain Validation Skills Delta V & MES Validation
Job Summary :
- The Lead Validation Engineer will oversee and drive commissioning and qualification (C&Q) activities for automation and process systems at a regulated manufacturing site .
- This leadership role is responsible for ensuring validation strategies align with regulatory expectations and project goals while mentoring a team of validation professionals and coordinating with cross-functional stakeholders .
Key Responsibilities :
Required Skills :
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
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Validation Engineer • Wilson, North Carolina, USA
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