Aseptic Validation Lead: Media Fill Expert

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

Benefits offered by this job

Four options of 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 senior validation professional to lead media fill design and execution for aseptic manufacturing in a US-based site. You will author validation protocols, review reports, and drive CAPA-related activities in collaboration with manufacturing, quality, and regulatory teams.

The role requires 8+ years in pharma/biotech validation and strong aseptic processing knowledge, with a focus on cGMP and regulatory expectations. Onsite work with full-time hours is expected.

Qualifications

• Bachelor's degree in Engineering, Life Sciences, or related field.
• 8+ years of pharmaceutical/biotech validation experience.
• Aseptic processing and media fill execution experience.
• Experience in sterile manufacturing environments.
• Deep understanding of aseptic processing and contamination control.
• Strong knowledge of cGMP and regulatory expectations.
• Technical writing of 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.
• Author and review validation protocols, reports, and risk assessments.
• Support investigations, deviations, and CAPAs related to media fills.
• Partner cross-functionally with Manufacturing, Quality, and Regulatory teams.
• Ensure compliance with cGMP, FDA, EMA, and global regulatory requirements.
• Drive continuous improvement in validation and contamination control strategies.

Skills

Media fill execution

Aseptic processing

Regulatory knowledge

Technical writing

Cross-functional collaboration

Independent leadership

Education

Bachelor's degree

Job description

LanceSoft is seeking a senior validation professional to lead media fill design and execution for aseptic manufacturing in a US-based site. You will author validation protocols, review reports, and drive CAPA-related activities in collaboration with manufacturing, quality, and regulatory teams.

The role requires 8+ years in pharma/biotech validation and strong aseptic processing knowledge, with a focus on cGMP and regulatory expectations. Onsite work with full-time hours is expected.