Senior Validation Engineer

Location: Greenville, NC (Onsite) | Hire Type: 6-Month Contract-to-Hire

Pay

Target Pay Rate: $75.00/hour (W2)

Benefits

• PTO
• Paid holidays
• BCBS medical plans
• Dental and vision plans
• 401(k)
• ESOP

• Opportunity for long-term employment through contract-to-hire conversion
• Opportunity to support a leading pharmaceutical manufacturing organization
• Work within a highly regulated aseptic manufacturing environment

About the role

Seeking a Senior Validation Engineer with Revalidation/Requalification experience to support aseptic manufacturing validation activities within a highly regulated pharmaceutical environment. This role will serve as a subject matter expert (SME) supporting revalidation and requalification activities for critical manufacturing systems and equipment.

Responsibilities

• Lead and support revalidation and requalification activities for aseptic manufacturing equipment and systems.
• Develop, execute, and review validation protocols, qualification documents, and final reports.
• Provide SME support for autoclave, isolator, and SIP validation activities.
• Evaluate validation requirements related to equipment changes, process updates, and lifecycle management.
• Partner with Engineering, Manufacturing, Quality Assurance, and Validation teams to ensure successful execution of validation activities.
• Support deviation investigations, risk assessments, and corrective/preventive actions (CAPAs).
• Ensure validation activities comply with cGMP, FDA, and applicable regulatory standards.
• Maintain accurate validation documentation and support audit and inspection readiness.

Requirements

• Bachelor's degree in Engineering, Life Sciences, or related technical discipline
• 10+ years of aseptic manufacturing validation experience
• Extensive experience with revalidation and requalification activities
• Strong expertise with:
  • Autoclave validation
  • Isolator validation
  • Sterilization-in-place (SIP) systems
  • Equipment qualification and lifecycle management
  • Validation protocols and reports
  • cGMP and FDA regulatory requirements
• Strong technical writing and documentation skills
• Ability to work independently as a validation subject matter expert

Qualifications

• Bachelor's degree in Engineering, Life Sciences, or related technical field
• 10+ years of validation experience within pharmaceutical or biotechnology manufacturing
• Proven experience supporting aseptic processing and sterile manufacturing environments
• Deep knowledge of equipment qualification and requalification processes
• Experience with autoclaves, isolators, and SIP systems
• Strong understanding of validation lifecycle principles and regulatory expectations
• Excellent communication, organization, and problem-solving skills