PURPOSE OF JOB ROLE:
The Engineering Team provides technical engineering and project management services for manufacturing, building, and utility equipment to support operations, validation, and capital projects. Engineering managers build, develop, and lead the engineering staff within specific functional area to align with site objectives. Individual to be responsible for Engineering support of Manufacturing operations for operational cGMP biologics production facilities and associated labs and ensure compliance with all applicable standards. The Utilities Engineering Manager leads a team responsible for engineering support of utility systems and building infrastructure. In addition, individual is accountable for the site's reliability program, energy and water conservation program, and CAD program.
KEY RESPONSIBILITIES: (10 bullet points maximum)
• Provide Engineering support services to the operation of a commercial biopharmaceutical manufacturing site. Assign and prioritize all work to ensure requirements, timelines, client's needs, and adherence to GSK standards and policies.
• Ensure site is compliant with applicable standards, policies, and regulations (GSK Global Engineering Standards, GSK Quality Management System, GSK policies, cGMP, SOPs, local and national codes, etc). Ensure a high level of compliance with cGMP, and support regulatory requirements such as validation and regulatory documents. Prepare and participate as needed in all audits and inspections by having a good knowledge of the systems and the facility and assuring all Engineering leads understand their role.
• Develop the engineering staff's capability and competency in technical, quality, safety, project management, and business management as applicable. Ensure each engineer's training is adequate and current to perform their assigned roles. Ensure duty holders are assigned per GSK standard roles and competent to perform role.
• Oversee and/or support engineering activities such as, (1) technology transfer and insource/outsource projects, (2) plant changeover / shutdown project management, (3) process system, equipment, instrumentation, and software specification, (4) generation of function tests, and commissioning / validation protocols, (5) development and maintenance of SOPs, (6) generation and maintenance of system life cycle documentation (Drawings, Design Files, FRS, SDDS, etc), (7) demonstrate advanced working knowledge of biotechnology production, quality systems, and commercial manufacturing systems, and (8) project management.
• Evaluate resource requirements (staffing, financial, and time) and provide resource management as required in order to meet site goals. Develop and manage departmental OPEX and CAPEX budgets as assigned. Lead cost reduction initiatives to achieve assigned targets.
• Communicate concerns and issues of staff, project status, performance and suggestions for improvement to management
• Demonstrate good project management skills (schedule, cost, communications, and resource management) to execute projects in a timely and cost effective manner. Well organized and able to multi-task in project environments, and skilled in technical communication.
• Develop organizational chart, staffing plan, job descriptions, select and hire staff to align with site objectives. Prepare, execute, and monitor staff development plans and administer performance evaluations and performance plans.
• Ensures self inspection procedures for area of responsibility are in place and in use.
• Demonstrated leadership skills and the ability to be able to deal with constant change.
• Perform (or delegate) the roles of Energy Manager and Water Manager for the site.
Bachelors Degree in Engineering
15+ years of relevant job experience
• Must be proficient with MS Word, Excel, PowerPoint, MS Project (or similar).
• Professional Engineering (PE) license or Chartered Engineering status preferred
• Understanding of basic Finance and Managerial Accounting principles
• Understanding of human capital management fundamentals
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