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.
• Directs all facilities driven capital improvement projects.
• Plan facilities organizational structure to accommodate growth and change in priorities for site master plan.
• Generates high quality Maintenance summaries.
• Develops training requirements for staff and assures training is effective.
• Communicates with Managers and other colleagues re: routine and exceptional events.
• Directs or leads investigations regarding deviations, out of tolerance condition, and unexpected results.
• Manages contractors for construction, maintenance, and cleaning, etc. as required.
• Contacts suppliers and vendors as required.
• Participates with other senior managers to establish strategic plans and objectives
• Accomplishes staff results by communicating updated organizational information, job expectations & supporting their work
• Plans, monitors, and appraises direct reports including performance competencies, goals & job results
• Coaches, counsels, and conducts disciplinary actions
• Develops, coordinates, and follows organizational systems, policies, procedures, and follows labor and capacity standards.
• HS Diploma or equivalent required and
• Bachelor's degree in a technical discipline (Mechanical, electrical or chemical engineering) with a minimum of 8 years experience in an Engineering/Facilities capacity and a minimum of 2 years supervisory experience in a related technical field or equivalent training and/or experience.
• Must have a minimum of 5 years experience in a cGMP, Life Science Company.
Knowledge / Skills / Abilities:
• Has a strong knowledge of building infrastructure, utilities and process equipment. Demonstrated experience in team managerial skills.
• Has a strong working knowledge of the regulatory compliance requirements for the production of biologicals used in clinical studies or commercial manufacturing are essential.
• Demonstrates a clear understanding of the contract manufacturing business and effectively manages facility's operations to address compliance, customer and business needs in a timely manner.
• Has a high degree of mechanical aptitude .
• Has excellent communication skills both verbal and written.
• Ability to understand and follow verbal or demonstrated instructions.
• Ability to receive and comprehend and to effectively communicate detailed information through verbal and written communication.
• Demonstrated leadership skills.
• Ability to work effectively as part of a team.
• Ability to use judgment as dictated by complexity of situation.
• Ability to evaluate technical data and write technical documents.
• Ability to make decisions based on a wide knowledge of factors where application of advanced or technical concepts is predominantly required.
• Ability to record data accurately and legibly.
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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