Job Summary
We are seeking a seasoned professional to lead our commercial manufacturing team, focusing on Vial Filling Equipment. This role will involve supporting complex manufacturing initiatives and providing strategic leadership.
Main Responsibilities
* Provide tactical and strategic management to support operational goals and project completion.
* Mentor and develop staff, ensuring efficient use of resources and high team productivity.
* Work with internal and cross-functional teams to plan and execute capital projects and network initiatives.
* Contribute to department objectives and establish strategic direction within the F&E team.
* Lead vial filling unit operations, collaborating with system owners to resolve equipment reliability issues and plan for long-term focus areas.
* Improve plant capability and equipment reliability through partnerships with F&E and plant leadership.
* Develop asset lifecycle management and long-range plans for equipment maintenance.
* Drive business process improvements and translate business needs into engineering technology solutions.
* Analyze alternatives and make recommendations for technical/business proposals.
* Identify areas for improvement and implement solutions.
* Ensure site readiness and compliance for audits and partner reviews.
* Train staff and enforce GMP standards and procedures.
* Support Business Continuity Plans by identifying gaps and implementing solutions.
* Manage department budgets and expenses.
* Stay up-to-date on compliance and regulatory aspects for operation and maintenance.
* Sustain a safe working environment by following environmental health/safety practices 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.
* Ability to translate strategic opportunities into tangible executable plans.
* Experience in developing strategies for new product introduction and new technology deployment.
* Day-to-day vendor management and contract negotiations.