Validation Engineer (Media Fill)

Job Description

Job Description

Job Title: Validation Engineer (Media Fill)

Location: Greenville, NC (Onsite)
Hire Type: 6-Month Contract-to-Hire
Target Pay Rate: $65.00/hour

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

Additional Benefits:

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

Job Summary:

Seeking a Validation Engineer (Media Fill Validation) to support aseptic manufacturing operations with a primary focus on media fill validation (aseptic process simulation/APS) activities. This individual will be responsible for planning, executing, documenting, and supporting validation studies while ensuring compliance with cGMP, FDA, EU Annex 1, and global regulatory requirements. The ideal candidate will have hands-on experience within a sterile manufacturing environment and a strong understanding of validation lifecycle activities.

Must Have Skills:

• Bachelor's degree in Engineering, Life Sciences, Microbiology, or related technical discipline
• 5+ years of validation experience supporting pharmaceutical manufacturing
• Significant experience with media fill validation / aseptic process simulation (APS)
• Sterile or aseptic manufacturing experience required
• Strong understanding of:
  • Media fills / aseptic process simulations
  • Validation lifecycle activities (IQ/OQ/PQ)
  • cGMP and FDA regulations
  • EU Annex 1 requirements
  • Validation documentation and technical writing
  • Deviation investigations and CAPA processes

Job Duties:

• Plan, execute, and document media fill (aseptic process simulation) studies.
• Develop and revise validation protocols, reports, deviations, and risk assessments.
• Support investigations related to media fill failures and implement corrective and preventive actions (CAPAs).
• Coordinate validation activities with Manufacturing, Quality Assurance, Engineering, Microbiology, and Validation teams.
• Ensure validation documentation complies with cGMP, FDA, EU Annex 1, and company quality standards.
• Support change control activities and assess validation impacts related to process or equipment changes.
• Participate in regulatory inspections, internal audits, and validation readiness activities.
• Maintain accurate validation records and support continuous improvement initiatives within the validation program.

Qualifications:

• Bachelor's degree in Engineering, Life Sciences, Microbiology, or related technical field
• 5+ years of validation experience in a pharmaceutical, biotechnology, or sterile manufacturing environment
• Hands-on experience supporting media fill validation activities
• Strong knowledge of aseptic processing and sterile manufacturing practices
• Excellent technical writing, problem-solving, and communication skills
• Ability to collaborate effectively with cross-functional teams

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.