Shire Purification Engineering Manager in Lessines (Baxalta), Belgium
- Responsible for performance management and professional development of direct reports. Allocates resources, assigns priority to tasks and acts as an advisor for Purification design, improvements, problem solving in delivery of value-added services for the Lessines Site. Manages his cost center budget, plan and contract internal and external resources.
2.Provides management oversight to ensure Purification equipments and related automation and clean utilties are properly designed, fit for intended use, operate in a safe and efficient manner, and are compliant with all regulatory requirements. Ensures equipment availability is adequate to meet manufacturing requirements. Ensures organizational agility in order for timely response and resolution to operational issues. Ensure redaction and execution of validation protocols. Supports audits.
3.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.
4.Accountable for the purification CAPEX definition, 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.
5.Accountable functional partner and decision maker on the plant engineering governance team. Aligns on site strategy and goals, and identifies and escalates Engineering issues, and informs team on deliverables to ensure continuous improvement.
Minimum Degree Required: University degree
Preferred Degree: Master
Certificate(s): Master degree in Engineering
Ten plus (10+) years of experience in a process engineering function within a biotech/pharmaceutical operations/ manufacturing environment. Knowledge of purification equipment & related clean utilities is required.
KNOWLEDGE, SKILLS AND ABILITY:
Proven track record of management/leadership effectiveness including engineering people development.
Clean process technical skills
Must have experience in project: design/construction/commissioning in a regulated environment.
Excellent communication, leadership, organizational and mentoring skils
Must be a team player prepared to lead, work in, embrace a team based culture.
Demonstrated experience in GEP, GMP and validation approach in pharmaceutical industries
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Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We strive to develop best-in-class products, many of which are available in more than 100 countries, across core therapeutic areas including Hematology, Immunology, Neuroscience, Ophthalmics, Lysosomal Storage Disorders, Gastrointestinal/Internal Medicine/Endocrine and Hereditary Angioedema; and a growing franchise in Oncology.
Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.