QC Instrument Validation & Calibration Specialist

LSC, Life Science Consultants; Dublin; On-site; EUR 55,000 - 75,000; Full time

Job summary

LSC, Life Science Consultants, South Dublin, seeks a Quality Control Technical Services Specialist to oversee calibration, qualification and maintenance of laboratory equipment in a cGMP setting. The role emphasizes adherence to validation protocols and data integrity for biopharmaceutical testing.

The ideal candidate will have a Bachelor's degree in a science field and at least five years' lab experience, with hands-on lifecycle knowledge of analytical equipment qualification and regulatory

Qualifications

• Bachelor's degree in a Science related field is required.
• Minimum of 5 years of laboratory experience in a cGMP laboratory environment with exposure to analytical instrument validation and data integrity assessments.
• Detailed knowledge of pharmacopeia analytical methodology, instrumentation and analytical techniques used for biopharmaceutical testing.
• Understanding of current regulatory requirements for cGMP laboratory equipment validation and electronic record integrity 21 CFR part 11.
• Hands-on lifecycle and validation experience with analytical equipment in QC.

Responsibilities

• Plan, supervise calibration, requalification and maintenance of laboratory equipment per CMMS Maximo.
• Qualify new laboratory equipment in a cGMP environment and write validation protocols and summaries.
• Review and audit trails as part of validation lifecycle for computerized lab equipment.
• Schedule and coordinate equipment repairs with vendors to minimize downtime.
• Participate in technical project teams as SME on instrument validation regulations and procedures.
• Ensure calibration/maintenance activities are tracked in CMMS Maximo.

Skills

Laboratory experience

Analytical instrumentation

Data integrity

Regulatory awareness

Project collaboration

Education

Bachelor's degree in a Science field

Tools

Maximo CMMS

Validation protocols

Job description

LSC, Life Science Consultants, South Dublin, seeks a Quality Control Technical Services Specialist to oversee calibration, qualification and maintenance of laboratory equipment in a cGMP setting. The role emphasizes adherence to validation protocols and data integrity for biopharmaceutical testing.

The ideal candidate will have a Bachelor's degree in a science field and at least five years' lab experience, with hands-on lifecycle knowledge of analytical equipment qualification and regulatory