Validation Engineer (Media Fill)

Validation

Contract to Perm
Contract to Perm
Job ID: 58146040

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.

Meet Your Recruiter

Alicia Alexander
Alicia Alexander
Alicia Alexander

Technical Recruiter & Team Mentor

Alicia Alexander is a Technical Recruiter and Team Mentor at Sterling Engineering with four years of recruiting experience and nearly three years with Sterling. She specializes in engineering, manufacturing, and technical recruiting, supporting roles across maintenance, reliability, operations, engineering, and industrial environments, including food and life sciences.

Alicia is passionate about helping people find careers where they feel genuinely happy, supported, and positioned for long-term growth. She enjoys building meaningful relationships with candidates, helping them take the next step in their careers, and supporting companies as they build strong, high-performing teams.

With a background in psychology and human resources from North Central College, Alicia brings a people-focused approach to recruiting. Her understanding of relationship building, communication, and candidate motivation helps her create successful matches between talent and opportunity.

Alicia is known for developing strong partnerships with both candidates and hiring managers, with a focus on creating long-term placements that benefit both the individual and the organization.

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