Senior Aseptic Validation Engineer - Media Fill Expert

Lancesoft; Greenville (NC); On-site; USD 69,000 - 91,000; Full time

Benefits offered by this job

Medical Insurance

Dental and Vision Insurance

401k Contributions

Critical Illness Insurance

Voluntary Permanent Life Insurance

Accident Insurance

Other Employee Perks

Job summary

LanceSoft is seeking a Staff Validation Engineer in Greenville, NC to lead media fill studies and author validation documents for aseptic processes. The role requires 8+ years in pharmaceutical validation and a background in sterile manufacturing.

You will collaborate across Manufacturing, Quality, and Regulatory teams to uphold cGMP standards, assess risks, and drive improvements in contamination control. This is a 06+ month assignment with a competitive hourly pay.

Qualifications

• Bachelor’s degree in Engineering, Life Sciences, or related field.
• 8+ years of experience in pharmaceutical/biotech validation.
• Aseptic processing and media fill execution in sterile environments.

Responsibilities

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

Skills

Aseptic processing

Media fill

cGMP

Regulatory expectations

Technical writing

Project leadership

Communication skills

Education

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

Job description

LanceSoft is seeking a Staff Validation Engineer in Greenville, NC to lead media fill studies and author validation documents for aseptic processes. The role requires 8+ years in pharmaceutical validation and a background in sterile manufacturing.

You will collaborate across Manufacturing, Quality, and Regulatory teams to uphold cGMP standards, assess risks, and drive improvements in contamination control. This is a 06+ month assignment with a competitive hourly pay.