CQV approver – C&Q – Validation Lead

Remote Role Y/N

No

Role Description

THE ROLE

As part of a significant expansion of the Carlow site, an exciting opportunity has come to join the science, engineering/ manufacturing & commercialisation team to support the transition of the Carlow facility from construction & project phase to a commercialisation of fully operational facility delivering life-saving products to patients.

THE AREA

The role will require the leadership of an experienced, energetic, and committed Senior/ Lead Engineering (CQV/ Technical Engineer) with broad experience in Vial and Syringe Filling operations and the below key areas.

• Vial and Syringe Sterile operations – Isolators, VHP, decontamination systems.
• Cleaning Validation in Biotech facility & Cleaning Processes
• Sterilisation – Autoclave & Load Qualification
• Single Use Technologies – SUT and SU components/ manifolds
• Filter Validation – Sterilising and Bioburden reducing Filter Validation & Process Validation
• Ancillary Equipment for Bio-processing – Tube Welders/ Sealers/ Filter Integrity / Glove Integrity Testing
• Formulation processing using DeltaV including Transfer Panel and Utility Qualification.
• Parenteral Product Visual Inspection (Automated Inspection).
• High Potency and ICH Q5 products & containment methodologies

The successful candidate should have demonstrated experience in at least 2 of these key areas and alongside new facility introduction experience.

THE EXPECTATIONS

Within the role you will be acting 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 within 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.
• Authoring and reviewing standard operating procedures and technical reports including PQ protocols.
• Technical review and approval of Commissioning protocols, Qualification protocols and Validation protocols executed by vendors, cross functional groups and/ or validation counterparts.
• Supporting regulatory submissions as required.
• Owning Change Management process for Equipment introduction within the assigned area for qualification / validation up to PQ stage.
• Effective application of Lean Six Sigma and Change Management tools in the Validation group by:
• Leading by example in achieving results by using industry standard tools and processes
• Facilitate problem solving & risk assessment (FMEA) projects/meeting.
• Make problems visible and strive for continuous improvement.
• Serving as a key member during internal audits and external inspections/audits.
• Supporting alignment and knowledge exchange with development organizations, other commercial nodes and external manufacturing partners.

THE QUALIFICATIONS / EXPERIENCE

This role requires an experienced individual with a minimum of 6 years directly related experience in academia, pharmaceutical or biotechnology industry – along with a working knowledge of current regulatory requirements and current Good Manufacturing Practices.

A self-starter and results-focussed, the successful candidate will have strong contemporary knowledge, and the ability to work independently and on multidisciplinary teams.

Preferred Experience and Skills:

• Minimum 6 years C&Q/ QA/ QC/ Validation experience in highly regulated industry.
• Minimum 2 years process equipment C&Q/ QA/ Validation experience on Greenfield / Brownfield, Large Scale Project or new facility introduction.
• Presenting of QA / QC / Validation documents to regulatory agencies/ inspectors and defending approach
• 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

Ideally

Relevant technical qualification(s) in Applied Pharmaceutical / Biological / Chemical sciences, Computer Sciences or applied Technical / Engineering qualification.

The successful candidate will also have a proven track record in delivering excellence.