Our client is a biopharmaceutical company focusing on discovering and delivering transformational medicines and products in several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, and women's health. They are currently seeking an individual to lead the collaboration between manufacturing and information technology stakeholders.
In this role you will:
- Enable the company's digital journey to the 'Connected Plant', transforming business operations while leading change management for the digital workforce across the Americas Manufacturing region.
- Deliver comprehensive technology solutions that address prioritized business problems and innovation needs.
- Provide leadership to deliver technology strategies that support efficiency, safety, and quality while eliminating waste and human error.
- Provide end-to-end technical solution leadership and business process alignment through the delivery and maintenance of manufacturing, packaging, site operations, and business technology solutions and systems.
Responsibilities:
- Assess and benchmark digitalization and Factory of the Future capabilities for the site, develop and communicate strategy and roadmap in close alignment with Site Leadership Team (SLT), IME network leadership, and Business Technology Solutions (BTS) capabilities
- Continuous improvement of site OEE, in close partnership with Op Ex, Operations, Production Scheduling, Packaging, and Engineering to achieve quantifiable OEE improvement in the following areas:
- Equipment availability
- Cycle time and line turn
- Reduce waste and improve quality
- Accountable for digitalization program enablement in capital plan and long-range plan
- An active member of the site leadership team with responsibility for support and continuous improvement of operations (compounding, filling) and packaging, ensuring unplanned IT interruptions are held to minimum impact on manufacturing production
- Ensure delivery of robust sustainable digitalization solutions that meet site and network priorities
- Coach, mentor and develop key talent, and demonstrate a willingness to make hard choices around people accountability and talent development
- Establish and advance a high-performing team of SMEs by recruiting, training, coaching, and developing people, clearly communicating goals, performance expectations, role responsibilities, and performance feedback
- Provide expert guidance on new technologies and emerging IT trends for process and business reengineering
- Liaise with Global BTS, OES, Infrastructure, and Quality teams ensuring high standards of service delivery and engagement to influence continuous improvement opportunities for site operations
- Ensure cyber and operations resilience, compliance with respect to data integrity and regulatory standards are maintained and adhered to across all site systems
- Support and provide domain expertise to the site on GxP, data integrity, and information security as well as internal and external audits
- Understand current system architecture and partner with key stakeholders and site leadership to future-proof' BTS solutions to ensure site stability of manufacturing operations
- Facilitate internal resources and external vendors in planning, building, verifying, and implementing technical solutions for day-to-day operations as well as IME and BTS strategic imperatives. Interface with equipment, software, and service vendors to ensure successful delivery, integration, and manufacturing validation
Qualifications:
- Relevant degree in IT, Computer Science, Mechatronics, Electronics, or similar
- 12+ years of relevant industry experience. Exposure to FDA, GMP, ISA95, safety, and environmental legislation. Experience in the pharmaceutical or life sciences industries preferred
- 5+ years proven track record in delivering manufacturing automation solutions in a similar environment
- 5+ years + of project management experience - a proven record of cross-functional project delivery
- 5+ years of leadership experience - direct reporting with demonstrated ability to motivate and develop teams in a matrix environment
- Systems background: ERP, MES, Data Historian (OSI PI), Packaging, Chromatography (Empower), and laboratory management systems
- Knowledge of SCADA Server Build/Maintenance (including platform understanding Intellution, Wonderware, etc.)
- Knowledge of PLC Communications (various protocols and connections to hierarchy)
- Knowledge of Serialization data management and security, related site-specific hardware performance integration, and hierarchy
- SQL Server Build/data management tracking and security
- Knowledge of Quality Assurance, SLC, Compliance, and Data Integrity
- Ability to manage and support manufacturing operations in conjunction with the site and global teams
- Proven ability to make clear and courageous decisions, and influence site leadership and key stakeholders at site, regional and global levels