Validation Engineer

ref. 01250

Validation Engineer

Asset Recruitment is recruiting a Validation Engineer for a 12-Month contract role, with a high likelihood for extension, on behalf of our client, a growing pharmaceutical manufacturer in Carlow.

Role

As part of a significant expansion project, the successful candidate will join their science, engineering/ manufacturing & commercialization team to support the transition of their new facility from construction & project phase to a commercialization of fully operational facility delivering life-saving products to patients.

Primary responsibilities include project validation support, counting on conducting equipment performance qualifications (specifically sterilization and cleaning validation) authoring project validation master plans; SOP and documentation updates; validation protocols and final reports, executing validation studies and resolving technical issues encountered during study, execution and analysis of validation data.

In this role, you be required to work in a cross-functional team and independently to accomplish validation project purposes. Minimal work direction needed, highly skilled and knowledgeable to the position.

The successful candidate will be an experienced, energetic, and committed Senior/ Lead Engineering (CQV/ Technical Engineer) with experience in Vial and Syringe Filling operations, new facility introduction and in at least 2 of the following key areas:
• Vial and Syringe Sterile operations – Isolators, VHP, decontamination systems.
• Cleaning Validation in Biotech facility & Cleaning Processes
• Sterilisation – Autoclave & Load Qualification
• Filter Validation – Sterilising and Bioburden reducing Filter Validation & Process Validation
• Single Use Technologies – SUT and SU components/ manifolds
• Ancillary Equipment for Bio-processing – Tube Welders/ Sealers/ Filter Integrity / Glove Integrity Testing
• Formulation processing using DeltaV including Transfer Panel and Utility Qualification.
• High Potency and ICH Q5 products & containment methodologies
• Parenteral Product Visual Inspection (Automated Inspection).

Responsibilities

Act as a technical SME & Senior CQ/ Validation Engineer reporting within Technical Engineering at Tier 1 and Tier 2 level as required.

The role will include –

• Work in a team of Validation professionals from ‘Intern’ level to Associate Director to own and execute the Validation & PQ aspects of the project.
• Oversee equipment C&Q within the assigned area with a view to ensuring right first-time C&Q and Validation effort.
• Act as SME on the process & equipment within the assigned area.
• Providing technical and validation oversight to process, design and project delivery teams and coaching to associate personnel within the assigned area.
• Implementing the requirements as outlined in the site & project Validation Master Plan(s).
• Coordination of engineering sub-teams in the assigned area during execution of Cycle Development & Validation activities.
• Technical review and approval of Commissioning protocols, Qualification protocols and Validation protocols executed by vendors, cross functional groups and/ or validation counterparts.
• Authoring and reviewing standard operating procedures and technical reports including PQ protocols.
• Owning Change Management process for Equipment introduction within the assigned area for qualification / validation up to PQ stage.
• Supporting regulatory submissions as required.

Requirements

• 6 years+ of C&Q/ QA/ QC/ Validation experience in highly regulated industry.
• 2 years+ Process equipment C&Q/ QA/ Validation experience on Large Scale Project or new facility introduction.
• Relevant technical qualification(s) in Applied Pharmaceutical / Biological / Chemical sciences, Computer Sciences or applied Technical / Engineering qualification.
• Experience in presenting of QA / QC / Validation documents to regulatory agencies/ inspectors and defending approach
• Experience in collaborating with other departments such as Automation, Engineering, Technical, Operations, EHS and QA
• SME on Equipment Qualification on any; Cleaning & Parts Washers for in-process components / Vaporised Hydrogen Peroxide Isolators / Clean Utilities & Transfer Panels / Vial & Syringe Filling & Inspection
• Working knowledge of ASTM E2500 / Eudralex / FDA / ISPE guidelines.
• Prior experience in drug product processing equipment, PQ, Process Performance Qualification and Validation, site readiness, batch record reviews, authoring documents subject to regulatory inspection.
• Project Management experience desirable