Commissioning & Qualification Engineer

Summary:
Our client is a bio pharmaceutical company based in Carlow looking for a Validation Engineer who will work as part of a significant expansion of our client’s site. This opportunity has come to join the Commercialisation team to transition from a project phase to a fully operational facility delivering life-saving products to patients.

Responsibilities:

• Engage in the early stages of the project, giving input into design by working with equipment vendors and global engineering teams, attending FAT and design reviews to represent client validation interests.
• Oversee equipment C&Q within the assigned area with a view to ensuring right first-time C&Q and Validation effort.
• Act as C&Q SME on the equipment within the area assigned.
• Executing with a view to leveraging testing from Commissioning and Qualification to PQ where possible.
• Providing technical and validation oversight to process, design and project delivery teams and coaching to associate staff within the assigned suite.
• Implementing the requirements as outlined in the site / C&Q and project Validation Master Plan.
• Coordination of engineering sub-teams in the assigned suite during execution of IQ/OQ / Cycle Development & Validation activities.
• Authoring and reviewing standard operating procedures and technical reports including IOC/ IOQ & PQ protocols.
• Technical owner of Commissioning protocols, Qualification protocols and input to Validation protocols executed by vendors, cross functional groups and/ or validation counterparts.
• Supporting regulatory submissions as required.
• Input to Change Management process for Equipment introduction within the assigned suite for qualification / validation up to PQ stage.
• Effective application of Lean Six Sigma and Change Management tools in the Validation group.
• 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.

Qualifications & Experience:

• Minimum 3 years process equipment C&Q/ Validation experience on Large Scale Projects.
• SME on Equipment Validation on any of; Parts Washer / Autoclaves / Vaporised Hydrogen Peroxide Sterilising Isolators / Clean Utilities – Transfer Panels & Formulation / Visual Inspection/ Single Use Technologies.
• Working knowledge of ASTM E2500 / Eudralex / FDA / ISPE guidelines / Revised Annex 1.
• Experience with liaising with other departments – engineering, technical, operations and QA.
• Experience with sterile processing and sterilisation technologies.
• Experience with cleaning and process validation, technology transfer, regulatory filing, and commercial drug product manufacturing of biologics is a plus.
• Prior experience in drug product processing equipment, PQ, Process
• Performance Qualification and Validation, site readiness, batch record reviews, authoring documents subject to regulatory inspection.
• Autoclave Qualification and Sterilisation Loads Cycle Development experience.
• Use of temperature mapping equipment such as Lives/ Kaye etc. and trending, analysing and interpreting complex data.
• This role requires an experienced individual with a minimum of 3 years directly related experience in academia, pharmaceutical or biotechnology industry – along with a working knowledge of current regulatory requirements and current Good Manufacturing Practices.
• Applicants with less than 3 years of direct experience may be considered for future, more junior roles.
• Visual Inspection technologies for Vial & Syringe.
• Vial & Syringe processing technologies; drug product filling, glass handling, tray handling, stoppering, capping and CCI.
• Formulation and Clean Utilities C&Q along with Single Use Technologies.
  Warehouse and CTU qualification advantageous.
• New facility brown/ green field facility experience.
• Small equipment qualification and validation; FITs, Scales, Tube Sealers/ Welders, Headspace analysers, Flowmeters, Mobile Vessels & Single Use Technologies.
• Project Management experience / training in use of Project Management tools.