The Head will lead and manage the engineering operation for the Thousand Oaks (TO) Manufacturing Site in California. The head reports directly to the Global Biologics Operation Unit (Bio OpU) Engineering leader, dotted line to the Site Leader, and provides holistic engineering and maintenance support to the site to sustainably achieve capacity plans and fulfillment targets. Maintains equipment and facilities, performs facilities management including operations of utilities and critical systems, provides engineering technical support, and capital planning and execution. Serves as a member of the TO Site Leadership Team, and serves as a standing member of the Global Biologics OpU Engineering Leadership Team and helps set strategic direction for site engineering organizations and is accountable for the Engineering related operating results at the TO site.
Watch: Career Advice
Maintenance, Utilities, and Calibration
Process and Reliability Engineering
Plant Engineering and Utilities
Process Automation Engineering
Site based Capital Engineering Project Management
Facilities and Site Services supporting the entire site
The Head of Site Engineering will ensure the operation, maintenance, and utilities for all equipment, and utility systems used to support manufacturing operations at the TO site. The Head of Engineering is responsible and accountable for:
Ensuring Facilities, Plants, Utilities and Equipment are properly maintained and are fit for intended use.
Ensuring Facilities, Plants, Utilities and Equipment are operated in a safe and efficient manner and is compliant with all regulatory requirement
Delivering compliant and robust engineered solutions to improve reliability and efficiency of systems and equipment based upon operational best practices and periodic reviews
Developing and managing technical and organizational agility for timely response and resolution to operational issues.
Developing talent and professional capabilities of the function.
Essential Duties & Responsibilities
•Responsible for performance management and professional development of direct reports. Accountable for performance management and professional development of the Thousand Oaks site Facilities and Engineering personnel. Allocates resources, assigns priority to tasks and acts as an advisor to Site senior management in delivery of value-added services for the Site. Manages budgets and contract resources.
•Provides management oversight to ensure the Site Facilities, Plants, Utilities and Equipment are properly maintained, fit for intended use, operated in a safe and energy efficient manner, and is compliant with all regulatory requirements. Ensures equipment availability is adequate to meet manufacturing requirements. Provides management oversight of delivery of coordinated major maintenance activities including scheduled plant shutdown. Ensures organizational agility in order for timely response and resolution to operational issues.
•Accountable for development of technical subject matter expertise and provision of adequate engineering resources (internally and externally) to ensure system reliability, robustness and maximum availability. Ensures delivery of compliant and robust engineered solutions to improve reliability and efficiency of systems and equipment based upon best practices and operational periodic reviews.
•Accountable functional partner and decision maker on the Thousand Oaks site cross-functional governance team as well as the Global Biologics OpU Engineering Leadership team. Aligns on site strategy and goals, and identifies and escalates Engineering issues, and informs team on deliverables to ensure continuous improvement and overall support related to manufacturing operations support.
•Accountable for the planning, execution, controls, and technical quality of deliverables for all site capital investment projects and technology transfers. Ensure that project sub-teams are resourced appropriately (internally and externally) to meet their goals and objectives and ensure that projects are on time and on budget.
•This position requires the ability to communicate clearly and accurately, verbally and in writing and a strong understanding and knowledge of engineering and maintenance functions. Ability to work in a fast-paced environment and handle multiple tasks simultaneously.
•The candidate will be expected to evaluate and prioritize activities to support the business and add value to the company while understanding the specific priorities at the site. Candidate will be required to carry a cellular device and be available to support production requirements at the site.
Living our leadership behaviors is a basic expectation for all Shire employees. Shire expects all employees to embody the following:
Leadership Behaviors
o Be Positive
o Be Accountable
o Be Results Oriented
o Be An Excellent Manager of Self and Others
•Problem Solving: Enlists sound judgment and implements analytical, creative approaches to solve complex problems. Demonstrates innovative problem solving and analytical skills.
•Team and Talent Development: Builds, mentors and coaches the Biologics Operating Unit Engineering team. Must possess strong leadership, team building and management skills. Acts as a positive, resilient and collaborative leader with a ‘can do’ approach.
•Business Acumen: Has a high level of business acumen and knowledge of the pharmaceutical industry. Has the necessary business knowledge to work with outside groups, such as HR, Finance and Legal.
•Communication: Develops and maintains strong relationships at various levels with partners. Influences key internal and external stakeholders. Utilizes excellent interpersonal skills to communicate at all levels and achieve outcomes.
•May perform other duties as assigned.
Qualifications
Qualifications
•Must possess strong knowledge of engineering operations (e.g. facilities, utilities, maintenance, and design).
•Experience managing engineering operations in a manufacturing environment.
•Experience with Quality Systems and Processes within an FDA regulated manufacturing setting.
•Demonstrated understanding of business drivers, customer needs and multi-site dynamics to create viable strategic plans.
•Proven track record of management/leadership effectiveness.
•Must possess strong ability to negotiate and influence others internally and externally.
•Capital budgeting experience is required.
Education and/or Experience
Bachelor’s degree in Engineering and fifteen plus (12+) years of experience in an engineering and/or facilities function within a biotech/pharmaceutical operations/ manufacturing environment. Demonstrated experience in bioprocess engineering and expert knowledge of systems/equipment/facilities/automation is required.
Twelve (10+) plus years of experience in management of engineering personnel and proven skills for the management of managers is preferred. Excellent communication, technical, organizational, leadership, and mentoring skills are required. Must be a team player prepared to lead, work in, and embrace a team-based culture.
Working Environment
•GMP plant environment with a combination of office, clean room, and critical systems space.
•Must be able to gown and work within ISO 5, ISO 7 and ISO 8 environments (grade A, B, and C)
•Incumbent should expect a fast and dynamic environment with a high emphasis on achieving results.
Physical Demand
The overall physical exertion of this position is moderate with the expectation that the individual has the ability to be mobile within all areas of the facility.
Send To A Friend
Posts
