Validation Lead

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Job Description

Job Title: Validation Lead

Start Date: ASAP

Job Type: Contract - 12 months (possible extensions based on performance)

Pay Rate: $80-99/hr

Location: Clayton, NC

Schedule: Onsite, Monday-Friday, 8:00 AM - 5:00 PM

Job Summary:

The Validation Lead is responsible for providing validation and technical support across pharmaceutical projects, including protocol development, execution, data analysis, and reporting for Installation, Operational, and Performance Qualification (IQ/OQ/PQ).

This role leads validation efforts for systems, equipment, and processes, ensuring compliance with regulatory standards and maintaining validated states throughout the project lifecycle. The Validation Lead serves as a subject matter expert and works closely with project teams to support commissioning, qualification, and continuous improvement initiatives.

Responsibilities:

• Prepare, execute, analyze, and report on IQ, OQ, and PQ validation protocols.
• Own and manage Change Requests (CRs) related to validation activities.
• Perform compliance and technical reviews/approvals of validation protocols and data.
• Author validation documentation including Validation Plans (VPLs), Project Quality Master Plans (PQMPs), and related deliverables.
• Independently execute validation activities and serve as a technical expert for new systems.
• Ensure all validation activities comply with regulatory, corporate, and site requirements.
• Lead validation deviation investigations, non-conformities, and root cause analysis efforts.
• Develop and update validation procedures and Configuration Item Lists (CILs).
• Write and review specifications, SOPs, and supporting documentation to maintain validated systems.
• Support FAT, SAT, and commissioning activities, transitioning into validation ownership.
• Identify and implement process improvements prior to change control.
• Provide oversight for contractor activities and scheduling as needed.
• Support budget tracking and validation resource planning.
• Lead validation workstreams in coordination with the Project Manager.
  
  

Required Skills & Qualifications:

• Bachelor"s degree in Engineering, Computer Science, or related technical field (or equivalent experience).
• Minimum of 7 years of validation or quality experience in a pharmaceutical environment.
• Strong knowledge of regulatory requirements and industry standards (e.g., 21 CFR Part 11, GAMP 5, ISO, FDA, ICH guidelines).
• Hands-on experience with validation lifecycle activities (IQ/OQ/PQ).
• Proven experience with root cause analysis and deviation investigations.
• Strong technical writing skills for validation documentation and procedures.
• Demonstrated leadership and project coordination experience.
• Ability to manage multiple priorities and meet deadlines.
• Pharmaceutical project experience is required.
• Experience with TIMS (validation software) is required.
  
  

Preferred Qualifications:

• Advanced degree (MS or equivalent) in a related field.
• Experience in pharmaceutical manufacturing environments and GMP compliance.
• Strong knowledge of standard operating procedures and documentation practices.
• Experience supporting commissioning and equipment qualification.
• Ability to interpret and develop technical documentation from equipment manuals.
• Strong interpersonal, communication, and team collaboration skills.
• Experience managing change within regulated environments.
  
  

Physical Requirements:

• Ability to move equipment or supplies up to 33 pounds.
• Ability to perform precise, hands-on work.
• Ability to sit or stand for extended periods (approximately 50% of the time).
• May require corrected vision (20/25) and color vision.
• Ability to climb ladders and work at elevated heights when needed.
• May occasionally work around hazardous or odorous materials.
  
  

Core Competencies:

• Seek Understanding: Demonstrates empathy, inclusivity, and emotional intelligence.
• Build Teams: Fosters collaboration, trust, and engagement across teams.
• Accelerate Development: Coaches others and promotes continuous improvement.
• Set Direction: Communicates vision and aligns work with strategic goals.
• Drive Outcomes: Ensures accountability, adaptability, and execution excellence.
  
  

Tools & Software:

• TIMS (Validation Management System) - required
• Microsoft Office Suite (Excel, Word, PowerPoint)
  
  

If you are interested in this role, please apply via the apply now link provided. Our overriding goal is to provide quality staffing solutions that help people, organizations, and communities succeed. Belcan is a leading provider of qualified personnel to many of the world's most respected enterprises. We offer excellent opportunities for contract, temporary, temp-to-hire, and direct assignments. We are the employer of choice for thousands worldwide. For more information, please visit our website at Belcan.com

EOE/F/M/Disability/Veterans

Belcan is an equal opportunity employer. Your application and candidacy will not be considered based on race, color, sex, religion, creed, sexual orientation, gender identity, national origin, disability, genetic information, pregnancy, veteran status or any other characteristic protected by federal, state or local laws.