Grifols Shared Services North America, Inc Senior Manager, Engineering 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.
Engineering manager will be responsible for managerial direction and technical leadership of GMP plant engineering needs for the Diagnostics business unit. Supports current GMP manufacturing production including system ownership of manufacturing utilities systems, automation systems, HVAC, and related GMP drawings and documentation. Supports and drives strategic business initiatives related to the future state of the Diagnostics antigen manufacturing organization.
Primary responsibilities for role:
Integral member of Diagnostics Plant Engineering management team.
Management duties include all aspects of plant engineering team management, utility, and automation management of bulk antigen production and finished product manufacturing facilities.
Coordinates with cross functional work-streams to ensure manufacturing operations are compliant with all internal and external quality, regulatory and customer requirements.
Works with Quality and Regulatory 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 project and departmental updates as required to management/Leadersip meetings, decision review boards, etc.
Responsible for site GMP automation, utility systems, and associated documentation
Supports design, start-up, commissioning, and qualification of new plant engineering investments
Participation in investigations and troubleshooting
Participation in regulatory inspections and contribute to regulatory filings
Responsible for department recruiting, talent development, training, and staff retention.
Responsible for Plant Engineering CAPEX and OPEX budgets
Knowledge, Skills, and Abilities:
Design and owners experience with process equipment and utility systems including equipment for fermentation, purification, high purity water, hvac, 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.
Prioritization, coordination and completion of Diagnostics GMP plant engineering project portfolio within schedule, budget and quality and/or customer constraints. Ability to understand spend and resource utilization reports, forecast resource constraints and develop resolutions.
Ensure site meets benchmarks set with other global Grifols sites to incorporate best practices within operations on site.
Other key indicators include inter-department collaboration; clear and concise communication to key customer groups, stakeholders and direct reports.
Proven experience in Automation and electrical systems and codes, including NFPA70, 70B, 70E, Siemens Apogee, and Rockwell Automation
BS Mechanical or Chemical Engineering, Science, or related field.
15+ years experience in pharmaceutical/biotech operations, with thorough working knowledge production unit operations, cGMPs, FDA regulatory guidelines and validation principles
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.
Location: [[mfield6]] : [[cust_building]]
Learn more about Grifols at http://www.grifols.com/es/web/international/home