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.

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-CQ

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.