Lead Cleaning & Equipment Validation Architect (GMP)

United Pharma

New Hampshire

On-site

USD 140,000 - 200,000

Full time

9 hours ago

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Job summary

United Pharma seeks a highly experienced Cleaning Validation & Equipment Validation Engineer to establish comprehensive validation programs in a GMP‑regulated biopharmaceutical setting. This role focuses on building programs from the ground up, authoring SOPs, and implementing sustainable validation processes with minimal supervision.

The candidate will lead cleaning validation, equipment qualification, temperature mapping, and requalification programs, with expertise in CIP, COP, SIP, and

Qualifications

8+ years in pharmaceutical/biotech validation.
Experience building cleaning validation programs from scratch.
Hands-on in Cleaning Validation, CIP/COP/SIP; IQ/OQ/PQ.
Direct Kneat experience required; SOP development and technical writing.

Responsibilities

Design, develop and implement cleaning validation and equipment validation programs with limited oversight.
Author SOPs, validation plans, protocols, reports, and lifecycle documentation.
Build and maintain equipment requalification programs (IQ/OQ/PQ).
Lead validation activities for autoclaves, parts washers, cold storage, and other equipment.
Drive CAPA, deviations, and change controls related to validation.

Skills

Cleaning validation

Equipment qualification

SOP development

Technical writing

GMP compliance

Education

Bachelor’s degree in Engineering or Life Sciences

Tools

Kneat

Ellab

TrackWise

Job description

The candidate will lead cleaning validation, equipment qualification, temperature mapping, and requalification programs, with expertise in CIP, COP, SIP, and

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