Strategic Operations Project Specialist
About The Position
The Strategic Operations Project Specialist is an intermediate level position for an individual with strong technical or quality knowledge and proven project experience. This individual will work closely with Manufacturing, MSAT, QA, Engineering, Validation and Project Management to achieve both site and department goals. This may include interdepartmental readiness, tech transfers, process improvement, procurement, quality systems and facility design changes. This position is responsible for being a technical representative for the manufacturing process on cross-functional teams. Responsibilities may include technical transfer and campaign readiness activities, continuous improvement projects, quality initiatives, and manufacturing investigations. The specialist role may support Strategic Operations Associates with training, project planning and execution, and issue resolution. This role may require direct customer interaction as part of Joint Project Teams (JPT) representation and pre-campaign activities. What you will get: An agile career and dynamic working culture. An inclusive and ethical workplace. Compensation programs that recognize high performance. Medical, dental and vision insurance. And much more!
Requirements
- A High School diploma or equivalent is required, Bachelor’s degree is preferred.
- Ability to work inter-departmentally and with customers.
- High level of suite specific operations and technical skills.
- Demonstrates role model behaviors for operating in a GMP manner, EPS behaviors- e.g. 3-way communication, questioning attitude
- Demonstrates role model safety behaviors
- Strong written and verbal communication skills
- Demonstrate ability for effective Planning, Organizing and Controlling competency
- Demonstrate sound decision making, considering broad scope of factors
- Able to wear required PPE on occasion
Responsibilities
- Maintains and develops Technical Knowledge on manufacturing equipment, Quality Control, Quality Assurance, and customer processes.
- Provide System Matter Expert support to manufacturing and other departments for the design and operation of process equipment.
- Support technical analyses on manufacturing equipment and processes using Plant Information data, batch record review, flow path analyses, and suite GEMBAs
- Support and own projects involving process improvements and technical changes driven by campaign readiness requirements.
- Own change requests and complete change request tasks to support project Completion Key Performance Indicators
- Creation and Management
- Review/Approve Batch Records to ensure operating procedures are in place and appropriate for each operation and equipment and processing activities are compatible with the intended Manufacturing design
- Own, drive and complete CAPA actions
- Perform other duties as assigned.
Benefits
- An agile career and dynamic working culture.
- An inclusive and ethical workplace.
- Compensation programs that recognize high performance.
- Medical, dental and vision insurance.
- And much more!
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
High school or GED
Number of Employees
5,001-10,000 employees
