Job Summary

The Advanced Operations Project Manager is responsible for the leadership and execution of various manufacturing transfer projects, process improvements, and/or quality & regulatory compliance projects related to daily production of instruments and consumables at Werfen. The Advanced Operations Project Manager has strong cross-functional leadership skills applicable to Werfen's highly technical, invitro diagnostic systems. This Manager leads teams, defines roles, and goals for project team members, and has regular interaction with internal and external personnel. The Advanced Operations Project Manager has high confidence and ability to lead strong technical engineers and scientists in a dynamic, interactive, and energetic manufacturing facility. The Manager is required to maintain consistent collaboration with all Operations functions, Research & Development, Quality, Regulatory, Finance, and Senior Management.

Key Accountabilities

• Provide technical and team leadership to one or more cross-functional project teams, ensure design requirements are met and comply with applicable standards.
• Identify and implement opportunities for continuous improvement.
• Responsible for coordination of technical resources to identify the root cause of any project issue, and develop and manage a plan to fix, test, and implement an appropriate solution through completion.
• Responsible for ensuring project risks, both technical risks and management risks, are identified and appropriately addressed within the project plan. Develop risk mitigation plans.
• Lead project team to complete all activities needed to conclude projects per plans. Responsible for project planning and scheduling, clarifying, and defining scope of work, and project specifications. Utilize deliverable milestone methods and critical path scheduling, conducting re-source planning and allocation, and developing tasks to meet business objectives.
• Responsible for conducting regular project team status meetings and reviews. Oversee validation project teams, prepare agendas, issue meeting minutes, and participate in development of quality plans. Develop and implement process controls for product transfer to manufacturing, or to new manufacturing site(s). Ensures deliverables are completed and documented.
• Write, review, and approve validations Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ) protocols and reports, Standard Operating Procedures (SOP), technical memos, and project plans for new products, processes, and equipment.
• Ensure all projects/processes are following FDA, Good Manufacturing Practices (GMP),
• Quality System Requirement (QSR), ISO-13485:2003, and other applicable regional requirements, as needed. Additionally, ensure and maintain compliance with the Company's quality system requirements through training and adherence to policies, procedures, and processes.
• Responsible for project communication to both the project team and executive management.
• Ensures that adequate equipment and material resources are available to advance the project and achieve goals and objectives.
• Able to resolve project team conflict through the application of good listening skills and negotiating skills.
• Performs other duties and responsibilities as assigned.

Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.

Networking/Key relationships

• External Suppliers
• Operations Management
• R&D Engineering (Mechanical, Electrical, Systems, etc.)
• Manufacturing Engineering
• Quality Engineering / Regulatory
• Supply Chain
• Logistics

Minimum Knowledge & Experience for the position:

• Bachelor's degree in engineering preferred, advanced degree a plus.
• Minimum ten (10) years of previous manufacturing experience within a regulated medical device manufacturing or pharmaceutical environment preferred.
• Full and comprehensive knowledge of the complete product lifecycle, including all aspects of product development from conception to manufacturing introduction for medical device/ diagnostic system preferred.
• Previous project management experience.
• Knowledge of lean manufacturing principles and latest manufacturing technologies.
• Experience in collaborating with domestic and international manufacturers is preferred.

Skills & Capabilities:

• Strong communication, problem solving, and time management skills.
• Excellent written and verbal communication skills.
• Strong leadership abilities in being able to meet deadlines.
• Ability to work as part of a team and resolve conflict.
• Extensive knowledge/experience in process and product manufacturing.
• Understanding of Food and Drug Administration (FDA), Good Manufacturing Practices (GMP), ISO 9000 Standards, and Occupational Safety and Health Administration (OSHA) regulations.
• Experience in creating and understanding engineering drawings, schematics, specifications, tolerancing, and bills of materials (BOMs).
• In-Depth experience with automation development to be able to suggest proper design improvements.
• Expertise in writing and performing validations in a regulated environment.
• Knowledge of statistical sampling and analysis
• Lean and Six Sigma green belt/ black belt methodologies a plus.
• Working knowledge of MS Office; knowledge of statistical software and large enterprise resource planning (ERP) system preferred.

Travel requirements:
Approximately 20%