Lead Validation Engineer
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Job Location:
Wilson, NC - USA
Monthly Salary:
Not Disclosed
Posted on:
3 hours ago
Vacancies:
1 Vacancy
Job Summary
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: Lead Validation Engineer
Work Location: Wilson NC 27893
Duration: 12 Months
Job Type: Temporary Assignment
Work Type: Onsite
Job Description:
- 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:
- Lead 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.
Required Qualifications:
- 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.
Preferred Qualifications:
- 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 projects.
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
