Job Description
This person will lead a team supporting commercial manufacturing with a focus on Vial filling equipment, driving complex and challenging manufacturing initiatives.
Key Responsibilities:
* Provide tactical and strategic management and leadership to support operational activities and project completion, staff development, team productivity, and resource optimization.
* Develop support structures with internal and cross-functional teams for capital projects, goal execution, and network initiatives. Provide input into department objectives and establish strategic direction within the F&E team.
* Lead vial filling unit operations regarding equipment, collaborating with system owners to resolve urgent day-to-day issues and plan for longer-term focus areas.
* Maintain and improve plant capability and equipment reliability in partnership with F&E and plant leadership, focusing on "predict and prevent" systems failures and recurrence avoidance. Strategize asset lifecycle management and long-range plans for equipment maintenance.
* Collaborate with diverse groups (Manufacturing, Quality, PD, Automation, IS, EHSS, Global Engineering) to drive new business processes, ensuring continuous and sustained improvements.
* Translate business needs into engineering technology solutions, leading analysis of alternatives and recommendations for technical/business proposals.
* Identify areas of potential improvement, conduct analyses, recommend solutions, sponsor improvement projects, and implement.
* Evaluate site readiness and compliance for internal audits, external agency audits, and partner audits. Ensure all staff are adequately trained and follow GMP standards and procedures.
* Support Business Continuity Plans by identifying gaps and developing/implementing solutions to close the gaps.
* Develop and adhere to department budgets and spend for operational and capital expenses.
* Stay 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 pertinent environmental health/safety practices, 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