Validation Lead

Position: Validation lead

Location: Apex, NC

Contract Duration: 6-month contract with likelihood of extension

Start Date: TBD

Key Responsibilities:

• Develop, review, and approve Qualification Protocols (IQ, OQ, PQ), Validation Master Plans (VMPs), User Requirement Specifications (URS), and other related documentation.
• Lead and manage the Commissioning, Qualification, and Validation (CQV) of systems, equipment, and manufacturing processes within a GMP environment.
• Perform and oversee risk assessments, impact analyses, and validation gap analysis to ensure the integrity and consistency of manufacturing processes.
• Support the qualification of equipment, utilities, and facilities, ensuring systems are designed, installed, and validated to meet GMP standards.
• Lead and execute process validation activities for critical manufacturing systems, including equipment, cleaning, and process qualification
• Collaborate with cross-functional teams, including Engineering, Quality Assurance (QA), and Manufacturing, to ensure effective implementation of validation strategies.
• Lead and support regulatory audits and inspections,
• Investigate deviations, conduct root cause analysis, and ensure CAPA activities are in place to address any qualification or validation issues.

Qualifications:

• Strong understanding of GMP, FDA regulations, ICH guidelines, and industry best practices related to qualification and validation.
• 10 years of experience in C&Q and Validation within a GMP-regulated industry (pharmaceutical, biotech, medical devices).
• Expertise in drafting and executing qualification protocols (IQ, OQ, PQ) and validation documentation (VMPs, URS, etc.).
• Experience with risk assessments, impact assessments, and regulatory compliance audits.
• Strong analytical, organizational, and communication skills.
• Bachelor's degree in Engineering, Life Sciences, or a related field (Master’s preferred)