Senior Aseptic Validation Lead - Media Fill (6mo Contract)

Integrated Resources, Inc.; Greenville (NC); On-site; USD 69,000 - 91,000; Full time

Job summary

Integrated Resources, Inc. seeks a senior validation specialist to lead media fill studies for aseptic manufacturing, author validation docs, and drive improvements across cGMP processes.

You will collaborate with Manufacturing, Quality, and Regulatory teams to ensure regulatory compliance and robust validation strategies. The successful candidate has 8+ years in pharma/biotech validation, strong aseptic processing experience, and proven technical writing skills to produce protocols and reports

Qualifications

• Bachelor’s degree in Engineering, Life Sciences, or related field.
• 8+ years of experience in pharmaceutical/biotech validation.
• Strong experience with aseptic processing and media fill execution.
• Experience in sterile manufacturing environments.
• Deep understanding of aseptic processing and contamination control.
• Strong knowledge of cGMP and regulatory expectations.
• Technical writing expertise in validation protocols and reports.
• Ability to lead complex validation projects independently.
• Strong collaboration and communication skills.

Responsibilities

• Lead the design and execution of media fill studies for aseptic manufacturing processes.
• Author and review validation protocols, reports, and risk assessments.
• Support investigations, deviations, and CAPAs related to media fills and aseptic processes.
• Partner cross-functionally with Manufacturing, Quality, and Regulatory teams.
• Ensure compliance with cGMP, FDA, EMA, and global regulatory requirements.
• Drive continuous improvement initiatives in validation and contamination control strategies.

Skills

Collaboration skills

Communication skills

Technical writing

Project leadership

cGMP knowledge

Regulatory knowledge

Aseptic processing

Media fill execution

Sterile manufacturing

Education

Bachelor's degree in Engineering, Life Sciences, or related field

Job description

Integrated Resources, Inc. seeks a senior validation specialist to lead media fill studies for aseptic manufacturing, author validation docs, and drive improvements across cGMP processes.

You will collaborate with Manufacturing, Quality, and Regulatory teams to ensure regulatory compliance and robust validation strategies. The successful candidate has 8+ years in pharma/biotech validation, strong aseptic processing experience, and proven technical writing skills to produce protocols and reports