Reporting to the Engineering Snr. Manger, this person is accountable for leading a team supporting commercial manufacturing with a focus on Vial filling equipment. The position will support complex and challenging manufacturing initiatives.

Key Responsibilities:

• Provide tactical as well as strategic management and leadership to provide operational support and project completion, mentoring, staff development, team productivity and efficient use of available resources.

• Planning support structures with internal/cross-functional teams for capital projects, goals and network initiatives execution. Providing input into department objectives and establishment of strategic direction within the F&E team.

• Lead the direction for vial filling unit operations for as it relates to the equipment; work together with the system owners to ensure both urgent day-to-day equipment reliability issues are resolved as well as longer term focus areas are planned for appropriately.

• Maintain and improve plant capability and equipment reliability in partnership with F&E and plant leadership and other technical staff in the network with a focus on “predict and prevent” systems failures and recurrence avoidance. Strategize asset lifecycle management and long-range plans for equipment maintenance.

• Work with diverse groups (Manufacturing, Quality, PD, Automation, IS, EHSS, Global Engineering) and drive new business processes to ensure continuous and sustained improvements.

• Translate business needs into engineering technology solutions. Lead analysis of alternatives and recommendations for technical/business proposals.

• Identify areas of potential improvement, conduct analyses, recommend solutions, sponsor improvement projects and implement.

• Ensure site readiness and compliance for internal audits, external agency audits, and partner audits. Ensure that all staff are adequately trained and follow all GMP standards and procedures.

• Support Business Continuity Plans by identifying gaps and develop/implement solutions to close the gaps.

• Develop and adhere to department budgets and spend for operational and capital expenses.

• Be knowledgeable and current on compliance and regulatory aspects for operation and maintenance, equipment validation and support regulatory inspections and audits.

• Support a safe working environment by complying with all pertinent environmental health/safety practice, rules and regulations.

Preferred Qualifications:

• Bachelor’s Degree in Engineering (Mechanical, Electrical or Chemical)

• Manufacturing experience in biopharmaceutical Formulation/Fill/Finish

• Solid leadership, technical writing, and communication/presentation skills

• Experience in change control, non-conformance, corrective and preventative actions, and validation practices

• Experience in developing strategies for new product introduction and new technology deployment

• Ability to translate strategic opportunities and emerging technology solutions into tangible pragmatic executable plans

• Ability to influence the development of business area strategy and engineering/equipment strategy where appropriate

• Ensure application of corporate blueprint and standards using business drivers to local business needs

• Development and presentation of project plans to senior management

• Day to day vendor management and contract negotiations with focus on equipment suppliers

• Independent, self-motivated, organized, able to multi-task in project environments and skilled in communication and collaboration

• Team player, prepared to work in and embrace a team-based culture that relies on collaboration for effective decision-making.

Travel at various times may be required to support execution of projects