Job Description – CQV Engineer
About the company: Innopharma Technical Services, part of Innopharma Group, specialise in the provision of highly skilled resources for Life Sciences industries.
Innopharma Technical Services in partnership with our leading Pharmaceutical/ Biopharmaceutical client companies is looking to recruit a CQV Engineer for their Dublin & Limerick site. As part of a significant expansion of our client facility, an exciting opportunity has come to join their Validation team.
Responsibilities:
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.
- 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 firsttime 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 2-5 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.
Note:
- Due to the nature of the business additional duties may be assigned from time to time.
- All applicants must be eligible to work in Ireland.
- All applicants must be willing to work in shifts, if required.
Job Type: Full-time
Application question(s):
- Are you eligible to work in Ireland without VISA sponsorship now or in future?
Education:
- Bachelor's (required)
Experience:
- CQV: 1 year (required)
- Process equipment : 1 year (preferred)
- Industrial regulatory: 1 year (preferred)
Work authorisation:
- Ireland (required)
Work Location: In person
Reference ID: INNO R-CQV