CQV Engineer

The Role:

As part of a significant expansion of the client site, an exciting opportunity has come to join the science, engineering/ manufacturing & commercialisation team to support the transition of a new Carlow high potency facility from construction, project phase to a fully operational facility delivering life-saving products to patients. Within your chosen role you will be acting as an intermediate engineer reporting within the GSEC model to Technical Engineering department, the role will include: – Act as C&Q SME on the equipment within the area assigned. As such you will be executing with a view to leveraging testing from Commissioning and Qualification to PQ where possible.

Responsibilities:

• 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 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.
• Support various organizational initiatives as needed (examples include EHS, workload forecasting, work standardization, etc).
• 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.

Education/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

Interested candidates should submit an updated CV.

Please click the link below to apply, call William Cunnage on +353 21 4297900 or alternatively send an up to date CV to william.cunnage@peglobal.net

***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***