Cqv Engineer

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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