21067 – Cleaning Support Specialist (Chemical Engineer) – Tipperary Contractor

Purpose

The Cleaning Support Specialist’s primary responsibility will be to have ownership of API equipment cleaning processes. Will manage and co-ordinate cleaning process documentation and change control in order to sustain, improve and track cleaning status and effectiveness. Recommends and implements measures to improve cleaning processes. Will interface with CDS chemists to develop cleaning regimes for new products being introduced to the facility. Supports migration of process knowledge for product technical transfers from facility.

Responsibilities

• Responsible for issuing and management of cleaning changes and documentation.
• Responsible for reviewing and incorporating relevant updates as communicated via the Technical Team Lead.
• Responsible for management and tracking of Cleaning validation parameters and commitments.
• Support for Cleaning Investigations
• Compilation of CPV reports, CAR, and APRs
• Ownership and management of changes.
• Generation and tracking of cleaning campaign documentation.
• Stewardship of validated campaign data.
• Liaising with product teams to align turnaround targets.
• Investigation support for Cleaning QNs.
• Assessments of OOTs.
• Support project assignments as required.
• Completion of validation reports.

Requirements

• Degree qualification in a science or engineering-related discipline.
• Knowledge of GMP standards.
• Good communication skills, both written and verbal.
• Strong technical writing skills.
• Previous experience in API or Drug Product manufacturing is desirable.
• Maintain accurate records in compliance with GMP expectations.
• Understand and internalise procedures relevant to GMP operations.
• Communicate clearly and concisely on technical issues.
• Deliver project goals on time.

First 6 months on site for training, the role will then be hybrid