Grifols · 12 hours ago
Validations, Maintenance and Calibrations Specialist
California, United States
Full-time
Onsite
Mid, Senior Level
$103K/yr - $155K/yr
5+ years expGrifols is a global healthcare company that has been working to improve health and well-being since 1909. The Validations, Maintenance and Calibrations Specialist is responsible for ensuring equipment and system readiness through validation, calibration, and preventive maintenance while collaborating with R&D and leading validation efforts.
BiotechnologyHealth CareManufacturing
Responsibilities
Schedule and perform validation studies to meet production and requalification, IQ, OQ, PQ, CV, and PV requirements. This position requires giving instruction to personnel in other departments over which he/she has no direct authority
Advise production managers and supervisors in the performance of validation activities and adapt the validation schedule to production requirements
Coordinate validation activities with managers, supervisors, and technicians/operators from R&D, Manufacturing, Quality, Instrumentation, GMP, and Engineering
Develop qualification and validation protocols/reports for manufacturing systems, processes, and equipment such as qualification/requalification, facilities, utilities, temperature-controlled areas, cleaning, etc. This position requires thorough knowledge of processes, equipment, and sterilization principles and concepts. This knowledge is used in the implementation of the "life cycle" approach to validation
Evaluate and analyze validation data collected during projects, verify adequacy of the information and compliance with regulations
Validation-related activities of production, calibration, maintenance, quality, and others
Perform pre and post calibrations of thermal monitoring equipment, place probes, and generate reports and graphs of data
Perform routine requalification’s on schedule, including writing protocols, performing validation runs, analyzing data, writing reports, and assembling final validation packets
Maintain accurate, succinct, and detailed documentation of activities and ensure paperwork from other departments is available and complete when required
Ensure paperwork from other departments is available and complete when required
Assist GMP, Quality, and various production personnel during inspections or audits conducted by internal groups or regulatory agencies
Onboarding new equipment: coordinate/ lead creation of SOPs ensuring all operational, maintenance and calibration aspects are included
Maintain full oversight of all equipment in the facility requiring preventive maintenance and calibration
SOP oversight for existing equipment ensuring preventive maintenance and calibration required is clearly stated in existing operating procedures
Serve as the key liaison between manufacturing and third-party providers to ensure proper maintenance and calibration is carried out
Qualification
Required
Requires a BS/BA degree in related field, such as STEM (Science, Technology (i.e. Industrial Technology), Engineering, and Mathematics)
Minimum 5 years in validations within a GMP-regulated manufacturing environment
Strong knowledge of current Good Manufacturing Practices (cGMPs) operating procedures, validation standards and guidelines, and standard operating procedures
Strong critical thinking and problem-solving skills
Ability to identify errors and provide corrective action
Ability to work with others in a team environment
Proficiency with data acquisition systems and thermal mapping tools
Strong quantitative, analytical, organizational, and communication skills
Ability to lead projects and proactiveness will be required
Preferred
Certification in validation or maintenance management (e.g., ASQ, CMRT) as a plus
Experience in maintenance and calibrations will be highly valued
Benefits
Medical
PTO
Up to 5% 401K match
Tuition reimbursement
Company
Grifols
Grifols is a global healthcare company.
10001+ employees
H1B Sponsorship
Grifols has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (2)
2023 (2)
2022 (1)
2020 (2)
Funding
Current Stage
Public CompanyTotal Funding
$2.51BKey Investors
Michael J. Fox Foundation
2025-01-14Grant· $21M
2024-06-04Post Ipo Debt· $1.41B
2024-04-23Post Ipo Debt· $1.07B
Leadership Team
Camille Alpi
Chief Human Resources Officer
Víctor Deu
Director of Planning & Control Department
Recent News
2025-12-24
Pharma Letter
2025-11-28
Company data provided by crunchbase