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Director, Engineering
Closing Date: October 1, 2010
| Company: | Oregon Bioscience Association
Portland, OR |
| Job Location: |
Hillsboro, OR (Washington County) |
| Employment Type: | Full Time |
| Department: | Genentech |
Description: | Director - Technology
Hillsboro Operations
Lead Genentech's Hillsboro Manufacturing Science and Technology Departments (MSAT) including manufacturing science and engineering functions in direct support of production. Support Operations departments in make, assess, release activities; plan and execute capital projects within the plant; collaborate with Corporate Engineering on major capital projects; work closely with Global MSAT, Process R&D, Regulatory Affairs and Quality, representing the plant on technology transfers, regulatory agency inspections and other issues and projects; foster innovation in technologies, processes and systems as part of continuous improvement and cGMP efforts. This position requires the incumbent to work within a high paced, complex, technically advanced manufacturing environment. Close collaboration with the other members of the Hillsboro Leadership Team in order to establish priorities and action plans is absolutely essential. The ability to quickly identify issues and find robust solutions, manage multiple tasks and projects simultaneously and partnering with other sites and business units is required for success in the position and environment.
| Duties: | Two specific departments each under the guidance of a Manager / Sr. Manager will reside within this organization:
1. Technical Operations - responsible for providing process engineering support to the Plant including detailed knowledge of all equipment and process operations, protein and product characteristics and critical quality attributes. Tech Ops will provide leadership to all process fit evaluations, determination of testing and validation requirements, execution of appropriate IQ/OQ, ownership of all product components including vials, stoppers, packaging materials, etc. Tech Ops will serve as the process experts within the plant and liason with Global MSAT and Process Development regarding all issues related to the product formulation, processing and stability.
2. Automation and Information Technology - responsible for maintaining all PLCs, Process control system (PCS), Manufacturing Execution System (MES), local support for SAP interfaces and local coordination of desktop services in conjunction with Corporate IT. Provides on-the-floor troubleshooting of all process related automation issues including assessment of instrumentation issues.
Provide leadership to meet goals in:
* Staff development assuring a diverse, well trained staff ready to take on new technology projects, troubleshooting of existing processes, and developing methodologies for continuous improvement.
* Developing appropriate business processes in order to successfully support and execute projects within the plant, both new process/equipment and process improvement.
* Safety, assuring that all processes are designed and operated in the safest possible manor, consistent with all appropriate regulatory and corporate requirements. Assures that entire process safety program is executed through FMEA and HAZOP
* In close collaboration with the Technical Services team, provide all appropriate technical support to technology transfer projects.
* Develop all specific process parameters / cycle development prior to turnover to Technical Services for validation activities.
* Quality and compliance assuring that the facility is in a constant state of inspection readiness, not only through physical conditions, but the condition of all required engineering documentation.
* Continuous process improvement through partnership with the Operational Excellence organization.
* Budgets
* Capital project management
* Component quality
The following are additional duties / responsibilities / accountabilities of the position:
* Review and approve GMP documentation and regulatory submissions.
* Provide senior leadership on projects, process improvements, and teams.
* Work in partnership with other Genentech staff to develop and champion policies, best practices, decisions and strategic plans.
* Establish and maintain solid working relationships with other Roche departments. Strengthen partnerships with other groups to meet department and company goals.
* Model site mission, vision and values. Hire, promote, and recognize for these. Participate in and promote continuing education for self and reports.
* Actively contribute to effective teamwork and quality decision-making as a member of the HFF Leadership Team.
| Qualifications: | Qualifications:
Minimum of BA/BS in physical science or engineering with advanced degree preferred in science, engineering. Minimum of 15 years managerial experience and technical work experience in the pharmaceutical industry, preferable in process science, manufacturing or engineering. Experience with aseptic processing, vial filling, automated vision systems, lyophylization are strongly desired. Demonstrated ability to lead, motivate and sustain creative output from a large, diverse technical staff. Broad and deep understanding of manufacturing equipment, facilities, regulatory expectations, RCA, CPI, |
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