Hiring Company: Grifols Diagnostic Solutions
Location: San Diego, CA
Job Type: Full Time
Compensation: $ TBD
Description: Responsible for maintaining GMP manufacturing equipment and systems in good working order while adhering to cGMP standards under the direction of the Maintenance and Calibration Manager on the Grifols Diagnostic Solutions site in San Diego, CA.
–Maintain manufacturing fill lines in an operational and compliant state.
–Duties include all aspects of GMP maintenance including but not limited to:
Ensuring that 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 laboratories, systems, clean utilities and production equipment.
–Assisting with the administration of technical training for existing staff and new hires.
–Planning GMP maintenance activities in partnership area managers.
–Coordinates with manufacturing, Pilot plant and validation functions to ensure manufacturing operations are compliant with all internal and external quality, regulatory and customer requirements related to GMP maintenance.
–Responsible for ensuring all documentation is adequately completed in CMMS system.
–Preparation for and support of regulatory inspections.
–Assist Management with Department recruiting, talent development / training and retention.
–To ensure all company and Site policies and procedures are adhered to.
–Perform continuous personal and department personnel development to improve maintenance and supervisory skills.
Key Performance Indicators:
–Completion of scheduled preventative maintenance: > 98% on time.
–DR’s/CAPA’s: < 10% overdue.
–Completion of scheduled training requirements on time.
–Deliver quality products and services on time to all customers, internal and external.
–Monitor processes and products to identify opportunities for continuous improvement and drive implementation.
Impact on the Organization:
Effective Team Leader, directly responsible for equipment upkeep. Provides key training to maintenance staff and reports key breakdowns and continuous improvement opportunities to upper management.
Trade School, Apprenticeship or 7+ years of work experience in one of the following disciplines: electrical, Instrumentation, machinist or mechanic.
English fluent in speaking / writing
–3+ years experience as a Master Mechanic in pharmaceutical/biotech operations, with thorough working knowledge of GMP maintenance production, unit operations, cGMPs, and FDA regulatory guidelines.
–Direct GMP maintenance experience with Fill lines, manufacturing equipment and utility systems. including high purity water.
–Strong leadership, organizational planning, in addition to strong technical background required to coordinate multi-disciplinary teams.
–Excellent interpersonal effectiveness and communication skills (written and oral) required interfacing across departments and management levels.
–Compliance: Thorough knowledge of GMPs, regulatory guidelines and quality systems.
–Operations: Experience working in a production and/or technical environment; thorough knowledge of production facilities, equipment and processes; understanding of tech transfer processes.
–Information Technology: Understand efficient application of information technology systems to support operations.
–Finance: Understanding of business drivers, key decision development criteria, basic accounting practices.
–Problem Resolution: Thorough understanding of problem definition, analysis and resolution methods; familiarity with continuous improvement principals and tools.
–Team Work: Ability to build and cultivate cross-functional (potentially cross-site) relationships to facilitate successful completion of operational objectives; ability to effectively lead cross functional teams.
This position will be based in San Diego, CA. Position may require travel up to 5% in the case of business need. Travel to other Grifols sites for benchmarking, participation in divisional teams / projects or in global initiatives may also be required. May be assigned to carry a primary phone, providing 24/7 site alarm coverage on a periodic rotational basis. May be required to provide support for Non-GMP mechanical/Facility repairs and maintenance.
Please apply at: https://career5.successfactors.eu/sfcareer/jobreqcareer?jobId=42161&company=Grifols&username=