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.

Location: Dublin & Limerick

Key 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 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.

Preferred Experience:

• 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.

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If you’re passionate about manufacturing excellence and eager to grow in a fast-paced, regulated environment, we want to hear from you.

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