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Grifols Shared Services North America, Inc Supervisor of Instrumentation in San Diego, California

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Summary:

This Instrumentation Supervisor will be a member of the Manufacturing Technical Support team at Grifols Diagnostic Solutions in San Diego, CA. The position is responsible for the completion of calibration, maintenance, and general support of all on-site equipment, instruments, and systems. The position is responsible for maintaining procedures and documentation for all calibration activities and supporting quality investigations. The position also maintains the MRO spare parts inventory for all on-site equipment and instrumentation.

Primary responsibilities for role:

● Completion of calibration and instrumentation repair activities according to schedule to minimize impact to production schedule.

● Supports investigation and resolution of all technical issues related to on-site calibrated instruments and systems.

● Designs calibration strategy for new and existing insruments, defining accuracy tolerances and determining / revising calibration intervals.

● Writes and revises calibration & preventative maintenance procedures for instrumentation.

● Utilizes SAP and Maximo CMMS to track and document all maintenance and calibration activities.

● Plans GMP maintenance and calibration activities, assigning tasks, reviewing work, writing appraisals and providing technical training.

● Supervises/executes the day to day operation of the MRO storeroom including monitoring/maintaining inventory levels, receipt and issuance of all parts.

● Leads improvement projects to upgrade on-site equipment and instrumentation with new technologies.

● Supports and helps drive investigations for process deviations, technical assessment of issues, root cause investigations, CAPA task management.

● Oversees the Temperature Monitoring System, including administration, calibration, repair, and validation activities.

● Researches and selects new equipment and reference standards based on engineering and calibration requirements.

● Manages external vendors to coordinate on-site and off-site calibrations.

Additional Responsibilities:

Knowledge, Skills, and Abilities:

Experience with Insrumentation associated with Fill Machines, Water systems, Laboratory equipment, Freezers, and other equipment/systems

  • Experience using SAP and Maximo platforms to track all plant maintenance and calibration activities

  • Understanding of instrument Calibration/Metrology practices and methods (pressure, temperature, pH, TOC, load cells, etc.)

  • Mechanical aptitude and familiarity with a broad variety of electronic test equipment and standards

  • Ability to read and interpret P&ID diagrams, electrical wiring diagrams, electronic schematics

  • Ability to generate and maintain system Documentation - Drawings, P&IDs, SOPs, URS, FRS, DDS

  • Working knowledge of cGMPs including equipment, automation, and quality systems requirements

  • Manufacturing experience - Filling, Oligosynthesis, Labeling, Packaging

  • Experience with Allen Bradley and Siemens PLC/HMI systems

  • Excellent interpersonal effectiveness and communication skills (written and oral) required to interface across departments and management levels

  • Experienced in reading and using schematics and P&ID drawings

  • Advanced computer skills

  • Project management skills

  • Ability to work independently, manage multiple priorities, and prioritize and complete activities on time

  • Lean manufacturing experience preferred

Education:

5 years of direct calibration experience in regulated GMP pharma or medical device industry / 10 years related experience

Equivalency

Depending on the area of assignment, directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements. Example: If a job level requires a Bachelor’s degree plus 4 years of experience, an equivalency could include 8 years of experience, an Associate’s degree with 6 years of experience, or a Master’s degree with 2 years of experience.

EEO Minorities/ Disability/Veterans

Grifols is committed to Equal Employment Opportunity (EEO) and to compliance with all Federal, State and local laws that prohibit employment discrimination on the basis of race, color, age, national origin, ethnicity, religion, gender, gender identity, pregnancy, marital status, sexual orientation, citizenship, genetic disposition or characteristics, disability or veteran's status or any other classification protected by applicable State/Federal laws.  We will consider for employment all qualified Applicants, including those with Criminal Histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance.

Req ID: 202628

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