Job Title: Utilities CQV Specialist
We are seeking a skilled Utilities CQV Specialist for an 11-month contract at our Grange Castle site.
Job Purpose:
The successful candidate will be responsible for implementing the commissioning and qualification of new/modified clean utilities and non-GMP utilities and controlled environmental devices sitewide. They will provide technical expertise to ensure that systems and equipment are installed, commissioned, and qualified to regulatory specifications.
Key Responsibilities:
* Develop and maintain documentation for cGMP commissioning/qualification of systems and equipment, including CTP/IQ/OQ/PQ protocols and reports.
* Manage system change controls and ECMs effectively.
* Participate in design reviews for new/modified utility systems.
* Conduct construction system mechanical completion walkdowns.
* Execute CTPs, IQ, OQ, PQ Protocols in the field.
* Perform temperature mapping of equipment.
* Verify pre and post study calibration verifications.
* Maintain SOPs for validation, validated manufacturing operations, and cGMP compliance.
* Develop and implement changes to resolve deviations/events effectively.
Required Skills and Qualifications:
* Bachelor's degree in engineering with a focus on mechanical or process engineering.
* Minimum of 3-5 years' experience in biotechnology or pharmaceutical GMP manufacturing environments.
* Experience in temperature mapping with LIVES XPertVal system is an advantage.
* Qualification of clean utilities or HVAC experience is beneficial.
* Proven ability to work independently and respond to business needs proactively.
* Excellent interpersonal and communication skills.
* Good documentation practice experience.
* Proficiency in reading and verifying P&IDs.