Description:
As a Project Manager - OsiPI Implementation, you will lead the successful planning, execution and delivery of projects focused on deploying and optimising OsiPI solutions. The role requires experience with Rockwell FTPS, PAS|X, Syncade, POMS, Camstar or other life sciences compatible MES solutions.
Key Responsibilities:
Under limited supervision and in accordance with all applicable federal, state and local
laws/regulations, the Companies’ policies, procedures and guidelines, this position is required to:
- Coordinate with internal MES teams and third parties/vendors.
- Review and map the manufacturing workflow which takes account of things such as the paper batch records, P&IDs, SOPs/Work Instructions, technology transfer reports, integration platform L0 to L4 systems interfaces.
- Design review of the material flow, business process flow diagram, data exchange between MES and other systems, MBR to accurately reflect the manufacturing process.
- Interface platform L0 to L4 systems (Control System, OSI-Pi, Standalone equipment).
- Review validation document (Desing Specification, FAT, SAT, UAT) and testing of MBRs.
- Establish, execute, and oversee project's operations (ie Budget, forecasting, margin, metrics billing/invoicing, purchase orders, MSA/ SOW/ SLA compliance, etc).
- Drive Metrics and Reporting and support Estimation and Planning.
- Manage the tracking/measurement and progress against established measures and metrics (eg. bid vs did, SLA, and any other operational or contractual measures).
- Adopt Program Governance. Develop and run a detailed project plan, monitor, and track progress.
- Establish, execute, and oversee a project's governance (i.e. stakeholder management, communication ceremonies, benefits management, change management, scope management, teamwork environment, onboarding, etc.)
- Ensure that all projects are delivered on time, within scope and within budget.
- Assist in the defining project scope and objectives, involving all relevant stakeholders while checking for technical feasibility.
- Manage changes to the project scope, project schedule and project costs using appropriate verification techniques.
- Track project performance, specifically to analyses the successful completion of short and long-term goals.
- Meet budgetary objectives and adjust project constraints based on financial analysis.
- Develop spreadsheets, diagrams, and process maps for Project-related documentation.
Key skills/knowledge/experience:
- Extensive relevant industry experience with in-depth understanding of MES Project management, in (MBR design, Batch Record, eBR implementation) Governance & Estimation and Planning/
- Specific experience within the Consumer, OTC, or pharmaceutical industry.
- GMP experience.
- Excellent communications problem-solving skills, along with team building capabilities.
- Demonstrated ability to work under guidance and effectively prioritize tasks in a dynamic environment.