Engineering & Electronics
PE Global is currently recruiting for numerous Validation Engineers on behalf of our client based in Carlow. These are all initial 11 month contract roles.
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.)
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 below –
- 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.
Within your chosen role you will be acting as part of a large team of engineers reporting within the Technical Engineering department, the role will include –
- 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.
- Execution in line with the site Continued Process Validation (CPV) program and supporting cross-site CPV as needed.
THE QUALIFICATIONS / EXPERIENCE
- This role requires an experienced individual with a minimum of 2 years directly related experience in academia, pharmaceutical or biotechnology industry – along with a working knowledge of current regulatory requirements and current Good Manufacturing Practices.
- With relevant technical qualification(s) in Applied Pharmaceutical / Biological / Computer / Chemical sciences or applied Technical / Engineering qualification, the successful candidate will also have a proven track record in delivering excellence.
- Minimum 3 years process equipment C&Q/ Validation experience
- 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 but not essential;
- 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
- 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.
Interested candidates should submit an updated CV.
Please click the link below to apply, call Kellie on 0214297900 or alternatively send an up to date CV to firstname.lastname@example.org