Maintenance Manager
CA-Emeryville, US
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Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions. |
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Summary:
The Manager, Maintenance provides managerial direction and technical leadership for all GMP and Non GMP Maintenance needs at the Emeryville facility. This role supports current GMP manufacturing production including maintenance of critical utilities systems, HVAC, BAS, process equipment, automated systems and new product introduction. This position also supports all strategic business initiatives that impact the future state of the Diagnostics antigen manufacturing organization.
Primary responsibilities for role:
• Is an isntegral member of the Diagnostics Maintenance and Calibration management team.
• Manages all aspects of GMP maintenance personnel, including the management of 3rd party suppliers, including but not limited to:
- Ensures that maintenance personnel are trained and qualified to perform assigned duties.
- Ensures that corrective and preventive maintenance are performed in an efficient and timely manner.
- Assists with the management and resolution of all technical issues arising on all site systems.
- Plans GMP maintenance activities, assigning tasks, reviewing work, writing appraisals and providing technical training.
- Provides direct supervision of maintenance personnel responsible for support of bulk antigen production, clean utilities and finished product manufacturing operations.
- Sets group policy regarding staffing, hours and job functions to meet the needs of planned projects and production.
• Coordinates with quality, engineering, manufacturing, technology development 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 QA / RA compliance groups to ensure continued regulatory certification of existing facilities and GMP certification of new facilities, equipment and processes as required by business need.
• Presents departmental updates as required to management meetings, decision review boards, etc.
• Participates in regulatory inspections and contribute to regulatory filings.
• Recruits, ensures talent development / training and retention.
• Ensures all company and Site policies and procedures are adhered to.
• Performs continuous personal and department personnel development to improve maintenance and supervisory skills.
Additional Responsibilities:
• Prioritization, coordination and completion of maintenance within schedule, budget and quality and/or customer constraints. Ability to understand spend and resource utilization reports, forecast resource constraints and develop resolutions.
• Other key indicators include inter-department collaboration; clear and concise communication to key customer groups, stakeholders and direct reports.
Leads a Team of highly skilled maintenance staff - 20"
Knowledge, Skills, and Abilities:
• 10+ years experience in pharmaceutical/biotech operations, with thorough working knowledge of GMP maintenance and production, unit operations, cGMPs, FDA regulatory guidelines and validation principles.
• Direct GMP maintenance experience with process equipment and utility systems including equipment for fermentation, purification, high purity water, clean steam, compressed gases and waste treatment.
• Strong leadership, organizational planning and project management skills, in addition to strong technical background required to coordinate multi-disciplinary teams.
• Excellent interpersonal effectiveness and communication skills (written and oral) required to interface across departments and management levels.
Education:
BS Mechanical, Electrical or Chemical Engineering, Science, or related field.
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.
Occupational Demands:
- May occasionally lift, carry, push, pull or otherwise manipulate objects up to 25 pounds in weight, and/or lift, carry, push, pull or otherwise manipulate objects up to 10 pounds in weight frequently or continuously.
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.
Pay scale of $120,000-$179,000 per year, depending on training, education and experience. This position is eligible to participate in up to 15% of the company bonus pool. We offer benefits including medical, PTO, up to 5% 401K match, and tuition reimbursement. We are committed to offering our employees opportunities for professional growth and career progression. Even though we are a global healthcare company with employees in 30 countries, Grifols prides itself on its family-like culture. Our company has more than tripled its workforce in the last 10 years — we’re growing, and you can grow with us!
Location: NORTH AMERICA : USA : CA-Emeryville:USEMV - Emeryville CA-Headquarters