What are the responsibilities and job description for the Associate Director Facilities position at WuXi AppTec?
Responsible for directing all facilities functions to ensure operational business units are supplied with necessary physical property to meet company objectives including facility operation, maintenance and engineering. Specific responsibilities include preventative maintenance of facilities / systems, monitoring, coordination with metrology
and validation, managing facilities change controls, troubleshooting equipment processes, supporting up-to-dates to as-built engineering drawings and Validation Master Plans, managing external contractors, writing reports and staffing and supervising a Facilities group competent in current Good Manufacturing Practices (cGMP) and cleanroom behavior. Interacts with internal departments as well as withbmaterial / equipment vendors and commercial partners. Assessing facility fit of incoming
programs. Establish a shift structure to support multishift operations as needed. Supports soft services such as custodial, food services and office supplies. Supports site security and environmental health and safety (EHS).
Responsible for providing facilities oversight during design, construction, star-t- up, commissioning, validation of capital improvements of existing and and new state of the art, multi-product contract manufacturing and testing facilities and their operations.
Remains current regarding technical engineering design requirements. Develops and / or modifies facilities / equipment systems to be in a compliant state. Prepares test plans / methods, commissioning protocols, Standard Operating Procedures (SOPs),
material specifications and investigations reports. Ensures group compliance with appropriate regulatory and / or engineering standards including but not limited to the Code of Federal Regulations (21CFR), International Society of Pharmaceutical Engineers (ISPE), American Society of Mechanical Engineers (ASME), and / or Federal, State, Local EHS regulations and building codes. Maintain compliance with all procedures, policies, and regulations and ensure timely response to regulatory issues and inspection findings. May also be responsible for facilities security and / or act as liaison to leasing and property
management organizations and planning commissions.
- Responsible for the direction of Facilities services including soft services such as custodial, food service and office administrative support.
- Develops budget projections, material and staffing forecasts.
- Develops SOP's, Test Reports, clean room certification and balan and Validation Protocols.
- Develops maintenance and certification schedules to meet customer and business goals.
- Provides accurate preventative maintenance forecasting methods with continuous improvement
- Implements and maintains personnel policies, procedures and production control systems.
- Ensures that all facility equipment is properly maintained, calibrated, qualified and / or validated.
- Evaluates new production procedures and technologies.
- Conducts failure analysis, root cause determination and corrective action determination.
- Updates "as-built" drawings as required.
- Directs utilization of equipment, facilities, and personnel to obtain maximum efficiency and meet organizational objectives.
- Examines equipment, processes, operations and organizational structure to determine time or quality revisions and suggests
improvements.
Knowledge / Skills / Abilities :
Our Values :
Integrity & Dedication, Working Together & Sharing Success; Do the Right Thing & Do it Right.
Our greatest asset is our people, WuXi is dedicated to providing opportunities for internal growth with direct access to a dedicated and accessible Human Resources team.
WuXi AppTec provides equal employment opportunity to all individuals regardless of their race, color, creed, religion, gender, age, sexual orientation, national origin, disability, veteran status, or any other characteristic protected by state, federal, or local law.
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