Shift Operations Manager

MSD

Carlow

Our Manufacturing Division is a team of dedicated, energetic people who are dedicated to being the most trusted supplier of pharmaceuticals and health products worldwide. Our facilities, along with our external contractors, suppliers, and partners, comprise an interdependent global manufacturing network that's committed to delivering a compliant, reliable supply to customers and patients on time, every time, across the globe. The Operations Manager will play a management role in the development of our Carlow drug product facility. The Manager will take ownership for designated suite and others as required. Responsible for the operations teams, process equipment and all activities affecting them. Provide leadership, cross functional promote and technical expertise to operations, maintenance and manage operations through design, construction, validation, start-up and commercial manufacturing. Ensure that objectives are effectively achieved, consistent with company requirements to ensure compliance, safety and reliable supply to our customers. The Manager will collaborate across functions, supporting, coaching and facilitating project sub-teams. Together, this dynamic group will meet the required project schedule milestones, in accordance with the applicable company standards for Quality and EHS compliance. RESPONSIBILITIES  Responsible for delivery of schedule milestones throughout the project duration. Collaborate and work cross functionally to develop and deliver on all aspects of the project through URS, FAT, SAT, IC, OC, IQ, OQ, PPQ and commercialization to meet schedule milestones. Driving operational and technical excellence to deliver all components of a stable process for PPQ, facility start-up and commercial supply, promoted by a flexible, collaborative, multi-skilled teamwork environment. Design and operationalise a successful operations team that delivers right-first-time formulation and filling of biologics and vaccines. Resolve issues and escalate risks in a timely fashion to the relevant on-site stakeholders. Comply with the current our manufacturing division, Quality and EHS Management System requirements, as relevant to the project and commercial operations. Ensure that the operations team receive appropriate resources and programmes to develop technical and other skills, to complete their jobs whilst stimulating personal growth and development in line with role. Develop and maintain training programmes. Drive effective writing/revising/ rolling out of accurate operational procedures, training materials and maintenance procedures for various IPT systems; ensure all work is subsequently carried out in line with same. Foster a culture of continuous improvement by deploying company Six Sigma tools and promote implementation of Model Area within operations from the start. EXPERIENCE, KNOWLEDGE AND SKILLS. Demonstrating energy and passion, the IPT Operations Manager, will be a role model for operational excellence, and will contribute to the organisation's overall capability to thrive and grow. Experience with facility commissioning and startup and advantage. Demonstrated site operations project experience, from capital project to continuous manufacturing operations. Proven track-record in delivering results in a world-class supply organisation. A strong career history in pharma (ideally aseptic filling) and familiarity with a highly regulated environment. Innovative thinker, with excellent decision-making and problem-solving skills. Experience of working in a cross functional environment. Demonstrated leadership with at least 5 years' experience in a people management role. Knowledge of and experience in applying Six Sigma and Lean methodologies. Positive, flexible action-oriented attitude. Technical Skills. Experience in sterile filling processes and aseptic manufacturing. Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices. Report, standards, policy writing skills required. Proficiency in Microsoft Office and job related computer applications required. Lean Six Sigma Methodology experience desired. Lead, promote, participate and supervise the implementation and maintenance of the relevant safety programmes. Delivery of safety, performance and quality goals. People Skills. The passion to expand the future of Carlow. Ability to participate in and lead highly-effective teams. The desire to continuously learn, improve and develop. A great communicator, decisive decision-maker with a proven ability to deliver excellence. Strong leadership and stakeholder management skills. Willingness to support the team and a strong focus on delivering excellence. A passion for coaching others by imparting your skill-set and expertise. High personal integrity, credibility, energy and flexibility. Model the company leadership behaviours and use the our principles to achieve project success. Build diverse talent with the capabilities necessary to succeed in commercial vaccine manufacture; inspire, reward and develop to ensure individuals reach their potential; make tough calls when necessary. Set clear performance standards; overcome obstacles; hold ourselves and others accountable for achieving results. Education Skills. Degree qualification or equivalent (Science, Engineering, Technical. Experience in aseptic manufacturing. Evidence of continuous professional development is desirable. Why is this a compelling position for a dynamic and ambitious leader in Biopharma to consider? This is a hugely exciting opportunity for an ambitious and experienced individual to play a key role in a dynamic, motivated, high-performing group at an exciting moment for our company’s expansion in Ireland. The role is a chance to shape the development of a state-of-the-art facility and holds future opportunities for advancement. The candidate will be actively supported and encouraged to continue their professional development. This Operations Manager role offers opportunities to progress in the company's growing Irish operation and across Global Operations. As an equal opportunity employer, we are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. Please don't hesitate to contact the Talent Acquisition Advisor assigned to this role should you need any support during our recruitment process. We are committed to flexible working where possible, and this is why our Company has introduced a new hybrid working model for office-based colleagues around the world. Please feel free to speak to us about what flexibility means to you during your application or click on the link to find out more about our hybrid working model. So, if you are ready to: Invent solutions to meet unmet healthcare needs, please apply today.  .

670 days ago