12597 – Validation Engineer – Sterilisation – Carlow Contractor

Purpose:

An exciting opportunity has come to join the Commercialisation team to support the transition from a project phase to a fully operational facility delivering life-saving products to patients. As part of a biotech processing facility one of the main technical areas that will require experienced, energetic and committed engineers is Sterilisation Validation (Autoclaves, SIP of vessels etc.)
The successful candidate(s) will need to have demonstrated previous experience in Sterilisation Validation. Each candidate will be involved in the project from an early stage the vendor Site Acceptance Test (SAT), at the earliest, through to the Performance Qualification. Levels of responsibility will vary during this timeframe as outlined:
• Installation to Mechanically Complete – C&Q Oversight.
• Site Acceptance Test – Attendance, hands-on vendor support and C&Q Oversight.
• Commissioning & Qualification – Hands-on C&Q support & Oversight throughout project lifecycle.
• Cycle Development – Execution of Cycle Development pre and post OQ phases.
• Performance Qualification – Responsibility for / Execution of all Performance Qualification testing.

Responsibilities:

• Engage in the early stages of the project, giving input into design by working with equipment vendors and global engineering teams 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 validation SME on the equipment within the area assigned. As such you will aim to leveraging testing from Commissioning and Qualification 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 / project Validation Master Plan.
• Coordination of and participation in engineering sub-teams in the assigned suite during execution of Cycle Development & Validation activities.
• Authoring and reviewing standard operating procedures and technical reports including PQ protocols.
• Willingness and ability to support morning / evening shift work during critical periods within the project lifecycle (Cycle Development and PQ.)
• 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 tasks for Equipment introduction within the assigned suite for qualification / validation up to PQ stage.
• Effective application of LeanSixSigma 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 team member during internal audits and to support external inspections/audits.
 Supporting alignment and knowledge exchange with development organizations, other commercial nodes and external manufacturing partners.
• Lead and support various organizational initiatives as needed (examples include EHS, workload forecasting, work standardization, etc.)
• Represent the site in internal collaborations through Manufacturing Division Validation Communities of Practice to include sharing of best practices in validation and investigation activities.
• Keep up to date with scientific and technical developments, best practices and attend seminars as required.
• Maintain continuous focus on quality and safety compliance and unflinching focus on the customer.
• Execution in line with the site Continued Process Validation (CPV) program and supporting cross-site CPV as needed.
• Project validation support including conducting equipment performance qualifications (specifically cleaning and sterilization validation.)
• Authoring project validation master plans; SOP and documentation updates.
• Authoring validation protocols and final reports.
• Executing validation studies.
• Analysis of validation data.
• Resolving technical issues encountered during study execution.

Minimum Qualifications and Experience: 

• Relevant technical qualification(s) in Applied Pharmaceutical / Biological / Computer / Chemical sciences or applied Technical / Engineering qualification.
• Minimum of 2 years directly related experience in academia, pharmaceutical or biotechnology industry.
• Minimum 3 years process equipment C&Q/ Validation experience.
• Working knowledge of current regulatory requirements and current Good Manufacturing Practices.
• The ability to effectively articulate understanding of process science.
• SME on Equipment Validation on any of; SIP / Autoclaves.
• Working knowledge of ASTM E2500 / Eudralex / FDA / ISPE guidelines.
• Experience with liaising with other departments – engineering, technical, operations and QA.
• Experience with sterile processing and sterilisation technologies.
• Experience with 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.
• SIP and subject matter extensive experience.
• 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.
• Desirable:
• Experience with process validation, technology transfer, regulatory filing, and commercial drug product manufacturing of biologics is a plus.
• Warehouse and CTU qualification.
• Visual Inspection technologies for Vial & Syringe.
• Vial & Syringe processing technologies; drug product filling, glass handling, tray handling, stoppering, capping and CCI.
• 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.
• Experience of DHT & Electron Beam, VHP Isolators also beneficial.
• Prior experience in drug product processing equipment, PQ, Process Performance Qualification and Validation, site readiness, batch record reviews, authoring documents subject to regulatory inspection.