Cleaning Validation Engineer - Pharmaceutical

Description

Pharmaceutical manufacturing plant have an urgent contract requirement for an experienced CLEANING VALIDATION Engineer.

Working within an existing manufacturing facility we are looking for a Cleaning Validation specialist who is able to help develop the cleaning validation strategy across the business, including the cleaning methodology. We are looking for someone who is able to prepare for the audit/inspection that will be taking place and work closely with the FDA on their findings

Project Scope:

Existing manufacturing facility:

• Series of upgrades in the existing facility to increase capacity of manufacture and to ensure operational effectiveness.
• Fit out of new building to increase capacity/batch manufacture.

Key Responsibilities:

• This individual is going to be involved in the routine validation activities on Process/Cleaning as well as working alongside the new projects and installations.
• Write validation protocols and reports and Actively drive protocols and reports through the approval phases.
• On-the-floor review and follow up on protocols in progress (execution mainly performed by production group).
• Execution of process commissioning & qualification tests in adherence with project schedule.
• Supporting process validation activities and CIP/Cleaning verification during the handover/Operational period.

Experience:

• Good cleaning validation background.
• In the short term this individual will be working in the new facility, with completing and executing protocols.
• Moving forward the Engineer will help develop the cleaning validation strategy across the business.
• Need to develop the Cleaning methodology and must be robust enough to stand up to an FDA inspection that will take place at the end of 2017.

Key Points:

• Implementation of a cleaning validation process.
• GMP environment.
• Understanding of FDA guidelines for a cleaning methodology.

Ideal Skills and Experience:

• Degree or HNC/D qualified in an Engineering based subject or related experience in a Validation role.
• Experience within Primary API manufacturing environment responsible for Cleaning Validation and process qualification of equipment to include Pan-dryer, Wipe film evaporator, Super critical extraction (CO2), Mobile vessels, high speed mills and filtration vessels. (CIP).
• 7-10 years' experience in process/cleaning validation in the chemical/pharmaceutical industry.
• Familiarity with unit operations involved in the manufacture of active pharmaceutical ingredients (API's).
• Compilation and development of associated Validation documentation in line with GMP standards