Senior Validation Engineer

Job Description

Job Description

Job Title: Senior Validation Engineer (Revalidation/Requalification)

Location: Greenville, NC (Onsite)

Hire Type: 6-Month Contract-to-Hire

Target Pay Rate: $75.00/hour (W2)

Benefits: PTO, paid holidays, BCBS medical plans, dental/vision plans, 401(k), & ESOP

Additional Benefits:

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

Job Summary:

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. The ideal candidate will have extensive experience in aseptic manufacturing validation, including hands-on expertise with autoclaves, isolators, sterilization-in-place (SIP) systems, and validation lifecycle activities. The Senior Validation Engineer will work closely with Quality, Manufacturing, Engineering, and Validation teams to ensure equipment and processes remain compliant with cGMP, FDA, and global regulatory requirements.

Must Have Skills:

• 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

Job Duties:

• 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.

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 required
• Strong understanding of validation lifecycle principles and regulatory expectations
• Excellent communication, organization, and problem-solving skills

Qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or genetic information.