Senior Manager, Maintenance Calibration

San Diego, CA, United States
Nov 20, 2020
Required Education
Bachelors Degree
Position Type
Full time
Job Summary:

Responsible for managerial direction and technical leadership of manufacturing maintenance and calibration needs for the business units. Supports current GMP manufacturing, including maintenance of process equipment, fill lines and associated manufacturing equipment. Supports the calibration needs of the business including manufacturing, utility systems and related business functions. Manages the Equipment Change Control Process (CCE). Participates on teams to improve legacy equipment and systems and to implement new equipment and systems for new products and processes.

Essential Job Duties:

  • Management duties include all aspects of manufacturing maintenance, site calibration personnel and the management of 3rd party suppliers, including but not limited to:
    • Providing direct supervision of manufacturing maintenance and calibration personnel responsible for support of manufacturing and related business functions
    • Ensuring that maintenance and calibration personnel are trained and qualified to perform assigned duties
    • Ensuring that calbration, corrective and preventive maintenance are performed in an efficient and timely manner
    • Assisting with the management and resolution of all technical issues arising on all site calibrated instruments and systems
    • Planning manufacturing maintenance and calibration activities, assigning tasks, reviewing work, writing appraisals and providing technical training
    • Setting group policy regarding staffing, hours and job functions to meet the needs of planned projects and manufacturing.
  • Coordinates with quality, engineering, manufacturing, and validation functions to ensure manufacturing operations are compliant with all internal and external quality, regulatory and customer requirements related to GMP maintenance and calibration.
  • Works with compliance groups to ensure continued regulatory certification of existing facilities and GMP certification of new facilities, equipment and processes as required by business need.
  • Participation in regulatory inspections and contribute to regulatory filings.
  • Department recruiting, talent development / training and retention.
  • Ensures all company and site policies and procedures are adhered to.
  • Perform continuous personal and department personnel development to improve maintenance and management skills.
  • Develops and delivers metrics for internal business needs as well as monthly Quality requirements
  • Manages the site Equipment Change Control process.
  • Develops departmental budget.
  • Manage other key performance indicators including inter-department collaboration; clear and concise communication to key customer groups, stakeholders and direct reports.

Job Requirements:

  • BS in Mechanical, Electrical or Chemical Engineering or other related field.
  • 5+ years experience in pharmaceutical/biotech operations, with hands-on experience in GMP maintenance and calibration, manufacturing operations, cGMPs, quality systems, FDA regulatory guidelines and validation principles. Experience in management with direct reports is required
  • Direct GMP maintenance and calibration experience with manufacturing equipment and utility systems.
  • Strong leadership, organizational planning and project management skills, in addition to strong technical background required to coordinate multi-disciplinary team
  • Excellent interpersonal effectiveness and communication skills (written and oral) required to interface across departments and management levels.
  • Ability to understand spend and resource utilization reports, forecast resource constraints and develop resolutions.

*This job description is accurate at the date of publication . It is intended to provide information essential to understanding the scope and general nature of the work performed by job holders within this position. This job description is not intended to be an exhaustive list of qualifications, skills, duties, responsibilities or working conditions associated with the position. Other duties may be assigned, and qualifications required may change over time.

EEO Minorities/Females/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.