Senior Laboratory Specialist

2 weeks ago

Dublin, Dublin City, Ireland beBeeLaboratory Full time €60,000 - €90,000
Senior Laboratory Specialist Job Description

We are seeking a highly skilled and experienced Senior Laboratory Specialist to join our team. As a key member of our laboratory operations, you will play a critical role in ensuring the reliability and efficiency of our equipment.

The ideal candidate will have a strong background in laboratory management, with experience in calibration, qualification, and maintenance of laboratory equipment. You will be responsible for planning and conducting routine calibration, requalification, and maintenance of laboratory equipment, as well as reviewing and filing related documentation.

You will also be responsible for planning, executing, and documenting the qualification of new laboratory equipment in a cGMP regulated environment. This will include writing equipment validation protocols and associated summary reports. Additionally, you will conduct periodic reviews of instrument validation as part of the validation life cycle.

In this role, you will work closely with quality control management to ensure that all equipment meets calibration and qualification requirements. You will also be responsible for scheduling and coordinating equipment repairs and maintenance with vendors/contractors, minimizing downtime and disruption to laboratory activities.

As a subject matter expert on instrument validation regulations and procedures, you will participate in technical project teams and provide guidance and support as needed. You may also be responsible for owning and project managing change controls and adherence to Change Control metrics.

This is an excellent opportunity for a skilled laboratory professional to take on a leadership role and contribute to the success of our organization.

Requirements:
  • Bachelor's degree in a Science-related field required
  • Minimum 3 years of laboratory experience in a cGMP laboratory environment, including exposure to analytical instrument validation and data integrity assessments
  • Detailed knowledge of the methodology, instrumentation, and analytical techniques used for biopharmaceutical testing
  • Understanding of current regulatory requirements for cGMP laboratory equipment validation and electronic record integrity

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