Calibration Manager

Summary:

The Calibration Manager is responsible for the overseeing all aspects of the site calibration program including scheduling, resource management, customer satisfaction, quality, auditing, innovation, and budget. The position is a technical leader for the site, responsible for developing and motivating a team of supervisors and calibration technicians across multiple sites, buildings, and processes to deliver exceptional results for manufacturing operations. The Calibration Manager sets the overall calibration strategy for the site to ensure overall program efficiency, compliance with regulations, and implementation of best practices and innovative technologies.

Primary Responsibilities:

• Manages to completion all calibration and instrumentation repair activities according to schedule to minimize impact to manufacturing.
• Manages team of Supervisors and Calibration Technicians including technical development, setting of goals and performance expectations, and succession planning.
• Implements continuous improvement projects to increase efficiency of site calibration program including optimizing calibration tolerances and frequencies, implementing new calibration standards, assessing in-house vs outsourced calibrations, streamlining calibration procedures, and performing criticality assessments.
• Benchmarks with other sites and organizations to ensure calibration program is implementing the latest best practices and innovative technologies"
• Manages annual budget and forecasting for the calibration area and identifies cost savings across the team."
• Owns investigations for calibration Out of Tolerances and Quality Notifications and ensures corrective and preventive actions are implemented on-time to prevent reoccurrence of events.
• Owns the site Asset Lifecycle Management Plan for calibrated instruments and prioritizes capital investments to upgrade instrumentation.
• Delivers timely resolution of all technical issues and investigations for calibration Out of Tolerances and Quality Notifications for on-site calibrated instruments and systems.
• Manages investigations for process deviations, technical assessment of issues, root cause investigations, CAPA task management.
• Utilizes SAP and Maximo CMMS to review calibration technician work orders and generates reports for investigations and metrics development.
• Designs calibration strategy for new and existing instruments, defining accuracy tolerances and determining / revising calibration intervals.
• Owns the Temperature Monitoring System, including managing of system upgrades and validation projects.
• Lead representative for any audit queries related to calibration area.
• Investigates innovative technologies and methods in the calibration area and leads projects to implement at the site. "
• Owns data integrity initiative for calibrated instruments to ensure compliance with standards and regulations. "
• Analyzes monthly team metrics, ongoing calibration program improvement projects, and compliance topics and presents data to upper management.
• Identifies and implements cost reductions by eliminating non-value-added work and reducing external calibration service purchase order costs. "
• Stays informed of industry best practices and innovative technologies, attends metrology conferences, and events, and implements standards across the site.

Knowledge, Skills and Abilities:

• Ability to present technical information confidently and clearly enough for a diverse audience.
• Proficient with setting budget and forecasting annual expenses.
• Proficient with Computerized Maintenance Management Systems to track all plant maintenance and calibration activities (SAP, Maximo)
• Strong working knowledge of instrument Calibration/Metrology practices and methods (pressure, temperature, pH, TOC, conductivity, flow, weight, time, etc.).
• Strong working knowledge of cGMPs including equipment, automation, and quality systems requirements
• Excellent interpersonal effectiveness and communication skills (written and oral) required to interface across departments and management levels.
• Proficient at reading and using schematics and P&ID drawings.
• Advanced computer skills including advanced Excel functions.
• Project management skills and ability to mentor team members to deliver projects.
• Lean manufacturing experience and ability to coach team members on identifying lean opportunities.
• Ability to supervise a team of calibration technicians with both technical and interpersonal skills to motivate, develop, and build morale.

Education:

Bachelors Degree o Equivalent.

Experience:

• 8-10 years related experience.
• 3-5 years’ experience in biotech/pharmaceutical regulated facility.
• 2-3 years supervisory experience.
• Experience with technical report writing for out of tolerances and quality event investigations.
• Experience presenting to auditors and addressing any audit questions or observations.
• Knowledge of Instrumentation associated with Filling Machines and Labelers, Water systems, Laboratory equipment, Freezers, and other equipment/systems highly preferred.

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 typically requires an Associate’s degree plus 2 years of experience, and equivalent could include 4 years of experience or a Bachelor’s degree.

Occupational Demands:

• Must be able to stand, walk, carry, crawl to access instrumentation and execute calibration activities.
• Must be capable to sitting for extended periods on the computer.
• Must be able to follow full gowning procedures to enter laboratory environment.
• Must be able to lift and carry 25 lbs.
• Must be able to manipulate tools, electronics, and machinery including grasping, lifting, pulling, rotating.
• Must be able to visually read instrument displays and small print for extended periods.
• Must be capable of working at heights with a ladder and wearing required safety protection.
• Must be able to work in cold environments inside cold rooms and freezers for extended periods.

Pay Scale:

The estimated pay scale for Calibration Manager role based in Emeryville, California is $122,017 - $152,522 per year/per. Additionally, the position is eligible to participate in up to 15% of the company bonus pool. We offer a wide variety of benefits including, but not limited to: Medical, Dental, Vision, PTO, up to 5% 401(K) match and tuition reimbursement. Final compensation packages will ultimately depend on education, experience, skillset, knowledge, where the role is performed, internal equity and market data. We are committed to offering our employees opportunities for professional growth and career progression. Grifols is a global healthcare organization with employees in 30 countries focused on patient health and providing impactful results. Since our humble beginnings in 1909, Grifols has been a family company that prides itself on its family-like culture. Our company has more than tripled over the last 10 years, and you can grow with us!

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.

Location: NORTH AMERICA : USA : CA-Emeryville:USEMV - Emeryville CA-Headquarters

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