Validation & Calibration Lead — Maintenance Specialist

Grifols; California (MO); On-site; USD 103,000 - 155,000; Full time

Benefits offered by this job

8% bonus pool eligibility

Medical, Dental, Vision

5% 401(k) match

Tuition reimbursement

Job summary

Grifols, a global healthcare company, is seeking a Validations, Calibrations, & Maintenance Specialist to join the Vista facility on-site. The role focuses on ensuring equipment and system readiness through validation, calibration, and preventive maintenance, while collaborating with R&D on new project implementation.

The ideal candidate has a BS/BA in a STEM field and at least 5 years of GMP-regulated validation experience, plus hands-on maintenance and calibration knowledge.

Qualifications

• BS/BA in STEM field required.
• 5+ years in validations within a GMP-regulated manufacturing environment.
• Experience in maintenance and calibrations valued.
• Certification in validation or maintenance management (e.g., ASQ, CMRT) a plus.

Responsibilities

• Schedule and perform validation studies to meet production and requalification, IQ, OQ, PQ, CV, and PV requirements.
• Advise production managers and supervisors in validation activities and adapt the validation schedule to production requirements.
• Coordinate validation activities with managers, supervisors, and technicians from R&D, Manufacturing, Quality, Instrumentation, GMP, and Engineering.
• Develop qualification and validation protocols/reports for manufacturing systems, processes, and equipment including qualification/requalification, facilities, utilities, and calibration.
• Evaluate and analyze validation data, verify adequacy, and ensure regulatory compliance.
• Perform routine requalifications on schedule, including writing protocols and final packets.
• Maintain accurate documentation and ensure paperwork from other departments is complete.
• Assist GMP, Quality, and production personnel during inspections or audits.
• Onboard new equipment: coordinate/lead creation of SOPs ensuring all operational, maintenance and calibration aspects are included.

Skills

cGMP knowledge

Critical thinking

Project leadership

Team collaboration

Data acquisition

Thermal mapping

Education

BS/BA in STEM

Tools

Data acquisition systems

Thermal mapping tools

Job description

Grifols, a global healthcare company, is seeking a Validations, Calibrations, & Maintenance Specialist to join the Vista facility on-site. The role focuses on ensuring equipment and system readiness through validation, calibration, and preventive maintenance, while collaborating with R&D on new project implementation.

The ideal candidate has a BS/BA in a STEM field and at least 5 years of GMP-regulated validation experience, plus hands-on maintenance and calibration knowledge.