Validation, Calibration & Maintenance Lead – Onsite

Grifols, S.A; Vista (CA); On-site; USD 103,000 - 155,000; Full time

Benefits offered by this job

Medical

Dental

Vision

Life insurance

PTO

Paid holidays

401(k) up to 5% match

Tuition reimbursement

Job summary

Grifols is seeking a Validations, Maintenance and Calibrations Specialist to join our Vista, California manufacturing team. The role is fully on-site and focuses on ensuring equipment readiness through validation, calibration, and preventive maintenance, leading validation efforts, and collaborating with R&D on new projects.

The successful candidate will oversee IQ/OQ/PQ, coordinate with diverse groups, maintain meticulous documentation, and support inspections.

Qualifications

• BS/BA in STEM or related field; equivalent mix considered.
• Minimum 5 years in validations within a GMP‑regulated manufacturing environment.
• Experience with maintenance and calibrations highly valued.

Responsibilities

• Schedule and perform validation studies to meet IQ/OQ/PQ, CV, and PV requirements.
• Advise production managers on validation activities and adapt to production needs.
• Coordinate validation with R&D, Manufacturing, Quality, Instrumentation, GMP and Engineering.
• Develop qualification and validation protocols/reports for systems and equipment.
• Evaluate validation data for adequacy and regulatory compliance.
• Perform pre- and post calibrations of thermal monitoring equipment.
• Maintain accurate documentation and ensure required paperwork is complete.
• Onboard new equipment by creating SOPs for operation, maintenance, and calibration.
• Liaise between manufacturing and third‑party providers for maintenance and calibration.

Skills

cGMP knowledge

Validation

Maintenance

Problem solving

Teamwork

Data acquisition

Thermal mapping

Analytical

Project leadership

Communication

Education

BS/BA in STEM

Equivalent combination

Tools

Calibration equipment

Validation software

Job description

Grifols is seeking a Validations, Maintenance and Calibrations Specialist to join our Vista, California manufacturing team. The role is fully on-site and focuses on ensuring equipment readiness through validation, calibration, and preventive maintenance, leading validation efforts, and collaborating with R&D on new projects.

The successful candidate will oversee IQ/OQ/PQ, coordinate with diverse groups, maintain meticulous documentation, and support inspections.