Validations, Maintenance and Calibrations Specialist

GRIFOLS, S.A.•Oceanside, CA

23d•$103,270 - $154,790•Onsite

About The Position

Fully on-site role is embedded within the manufacturing team and is responsible for ensuring equipment and system readiness through validation, calibration, and preventive maintenance. The specialist must operate autonomously, lead validation efforts, and collaborate closely with R&D on new project implementation. This role will not only be dedicated to the Vista facility but providing validation support to all GBS locations and processes.

Requirements

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.
Requires a BS/BA degree in related field, such as STEM (Science, Technology (i.e. Industrial Technology), Engineering, and Mathematics).
An equivalent combination of education and experience may be considered based on business need.
Minimum 5 years in validations within a GMP-regulated manufacturing environment. Experience in maintenance and calibrations will be highly valued.

Nice To Haves

Certification in validation or maintenance management (e.g., ASQ, CMRT) as a plus.

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