Fill Finish Validation Engineer

KKR Consulting; New York (NY); On-site; USD 80,000 - 110,000; Part time

Job summary

A leading consulting firm is seeking a Fill-Finish Validation Expert in New York to support projects in pharmaceutical manufacturing. This role requires expertise in Air Visualization, Smoke Studies, and VHP qualification, along with strong knowledge of aseptic processes. Candidates should have at least 5 years of experience in fill‑finish validation and an understanding of GMP guidelines. This is a contract position that offers an opportunity to impact packaging and assembly operations directly.

Qualifications

• 5+ years of fill‑finish or aseptic validation experience in pharma/biotech.
• Proven experience with Air Viz, Smoke Studies, and VHP decontamination.
• Strong understanding of GMP, Annex 1, and FDA aseptic guidelines.
• Excellent documentation and technical writing skills.

Responsibilities

• Lead and execute Air Visualization (smoke) studies for aseptic processing areas.
• Plan, perform, and document VHP cycle development and validation for isolators and cleanrooms.
• Support equipment and facility qualification for fill‑finish and packaging systems.
• Collaborate with cross‑functional teams to ensure compliance with cGMP and FDA requirements.
• Prepare and review validation protocols, reports, and deviations.
• Participate in audits, inspections, and readiness reviews.

Skills

Air Visualization

Smoke Studies

VHP qualification

Aseptic manufacturing knowledge

Cleanroom environment knowledge

Education

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

Job description

Talent Acquisition Specialist @ KKR Consulting

Job Title: Fill-Finish Validation Expert

Location: New York (Onsite)

Role Overview: We are seeking experienced Fill-Finish Validation Experts to support upcoming projects in packaging and assembly operations. The ideal candidate will have deep expertise in Air Visualization (Air Viz), Smoke Studies, and Vaporized Hydrogen Peroxide (VHP) qualification, with strong knowledge of aseptic manufacturing and cleanroom environments.

Key Responsibilities:

• Lead and execute Air Visualization (smoke) studies for aseptic processing areas.
• Plan, perform, and document VHP cycle development and validation for isolators and cleanrooms.
• Support equipment and facility qualification for fill‑finish and packaging systems.
• Collaborate with cross‑functional teams to ensure compliance with cGMP and FDA requirements.
• Prepare and review validation protocols, reports, and deviations.
• Participate in audits, inspections, and readiness reviews.

Qualifications:

• Bachelor’s degree in Engineering, Life Sciences, or related field.
• 5+ years of fill‑finish or aseptic validation experience in pharma/biotech.
• Proven experience with Air Viz, Smoke Studies, and VHP decontamination.
• Strong understanding of GMP, Annex 1, and FDA aseptic guidelines.
• Excellent documentation and technical writing skills.

Seniority Level: Mid‑Senior level. Employment Type: Contract. Industries: Pharmaceutical Manufacturing and Biotechnology Research.

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