Job Title: Senior Commissioning & Qualification Engineer (Dublin West)
About the company: Innopharma Technical Services, part of Innopharma Group, specialise in the provision of highly skilled resources for Life Sciences industries.
In partnership with a leading Biopharmaceutical client company, we are now looking to recruit a Senior CQV Engineer for their Dublin West facility. As part of a significant expansion of our client’s facility, an exciting opportunity has come to join their Validation team.
About the Position:
The successful candidate will be responsible for C&Q deliverables and follow assigned systems through to the Equipment Performance Qualification, Validation and PPQ – including filing with regulatory bodies.
Key Responsibilities:
• Engage in the early stages of the project, giving input into design, attending FAT and design reviews. 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.
• Leveraging testing from Commissioning and Qualification to PQ where possible.
• Providing technical and validation oversight to process, design and project delivery teams.
• Implementing the requirements as outlined in the site / C&Q and project Validation Master Plan.
• Coordination of engineering sub-teams during execution of IQ/OQ/Cycle Development & Validation activities.
• Authoring and reviewing SOP’s 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.
• Facilitate problem solving & risk assessment (FMEA) projects/meeting.
• 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.
Experience and Skills:
• Degree qualified in Science or Engineering related discipline.
• Minimum 5 years process equipment C&Q/ Validation experience on Large Scale Projects
• Working knowledge of ASTM E2500 / Eudralex / FDA / ISPE guidelines / Revised Annex 1
• Prior experience in drug product processing equipment, PQ, PPQ and Validation, site readiness, batch record reviews, authoring documents subject to regulatory inspection.
• A self-starter and results focussed.
• Accountable for commitments, decisions, actions and behaviours.
• Ability to work independently and on multidisciplinary teams.
• Excellent oral and written communication skills.
