Grifols Shared Services North America, Inc Lead Mechanic in Emeryville, California
Grifols is a global healthcare company whose mission is to improve the health and well being of people. Our three divisions –Bioscience, Diagnostic and Hospital–develop, produce and market our innovative products and services to medical professionals in more than 100 countries.
We are committed to fostering an environment that creates continuous learning opportunities and encourages professional development and growth. As a company devoted to improving the health and well-being of people, we are looking for talented professionals worldwide. Make a difference and join us in this challenging and rewarding enterprise.
Responsible for maintaining and keeping buildings, clean utilities, production equipment and systems in good working order while adhering to cGMP standards under the direction of the Maintenance Supervisor on the Grifols Diagnostic Solutions site in Emeryville, CA.
Primary responsibilities for role:
Lead Mechanic duties include all aspects of GMP maintenance, including the management of 3rd party suppliers, 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. Overseeing mechanical tasks assigned to maintenance mechanic team, reviewing work and ensuring that paperwork is free of compliance gaps.
Providing direct supervision of GMP maintenance and calibration personnel responsible for support of bulk antigen production, clean utilities and finished product manufacturing operations.
Coordinates with 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.
Maintain all Mechanical spaces and clean utilities inspection ready at all times.
Responsible for ensuring all documentation is adequately completed in MAXIMO.
Preparation for and support of regulatory inspections.
Assist Supervisor with Department recruiting, talent development / training and retention.
To ensure all company and Site Engineering policies and procedures are adhered to.
Perform continuous personal and department personnel development to improve maintenance and supervisory skills.
Knowledge, Skills, and Abilities:
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, 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.
Trade School, Apprenticeship or 8+ years of work experience in one of the following disciplines: plumbing, pipe fitting, welding, electrical, Instrumentation, refrigeration, HVAC, equipment or plant operator, machinist, mechanic, steamfitter, or boiler mechanic
2+ years experience as a Senior Mechanic in pharmaceutical/biotech operations, with thorough working knowledge of GMP maintenance production, unit operations, cGMPs, and FDA regulatory guidelines.2+ years experience as a Senior Mechanic in pharmaceutical/biotech operations, with thorough working knowledge of GMP maintenance production, unit operations, cGMPs, and FDA regulatory guidelines.
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 an Associate’s degree plus 2 years of experience, an equivalency could include 4 years of experience or a Bachelor's degree.
Location: [[mfield6]] : [[cust_building]]
Learn more about Grifols at http://www.grifols.com/es/web/international/home