The PositionThis role provides directions to shift personnel in a chemical/pharmaceutical processing setting, guided by established policies and precedents. Interprets and executes policies, prioritizes resources with a focus on safety and quality, in a regulatory environment where judgment and initiative are required in resolving problems and making recommendations. We currently have two openings on the team supporting this scope of work.
RelationshipsReports to Manager.
Essential Functions- Provides technical and administrative supervision to assigned operational area
- Manage/supervise incidents, prepare daily status reports, delegate resources, conflict resolution and leverage support systems as needed
- Schedule and utilize personnel, material, and facilities to ensure schedules and goals are met
- Establish and maintain a variety of records and reports monitoring internal operating controls, which includes entering Oracle data for the use of the raw materials quantities, cycle time for batches, the pack out quantity of batches, the start, stop and completion of batches and cleanings
- Provide training in manufacturing techniques, policies, and procedures and/or safety and environmental procedures
- Establish & maintain good & effective communication with all stakeholders
- Represent the manufacturing function in meetings and discussions with other functional areas regarding manufacturing standards and operations
- Responsible for quarterly inventory count for assigned area
- Manage team, to include interviewing/hiring talent, providing coaching, mentoring, career development guidance & performance management addressing performance/behavioral & related disciplinary actions. performance management
- Provide after-hour warehouse support
- Responsible for any fire alarm on site and work with outside emergency responders and other service providers as needed
- Responsible for writing work orders and hot work, line break and confined space permits
- Provide leadership and mentorship for process technician personnel
- Follow all safety & environmental requirements in the performance of duties
- Other accountabilities as assigned
Physical RequirementsMoves equipment &/or supplies weighing up to 33 pounds within the facility using various body positions. Routinely operates & inspects manufacturing equipment using hands. Strap & unstrap pallets using hands. Must be able to be on your feet for up to a 12-hour shift. May require corrected vision to 20/20 or 20/25 based on role. May require color vision based on role. Occasionally ascends/descends a ladder. May be required to work at elevated heights. Occasionally works around odorous &/or hazardous materials. May be required to wear latex gloves. May perform critical job functions in extremely cold work environments depending on site. May position oneself within confined spaces for inspection if required of the role. Ability to work in loud noise environments with hearing protection. May be required to secure a motorized vehicle license & operate a motorized vehicle based on the role.
Development of PeopleSupervisory. Ensure that reporting personnel have individual development plans (IDP), with annual goals and measurements that are consistent with the priorities of the business, and that interim reviews are held so that their work is focused on those priorities, and they understand their level of accountability for results and the measurement process. Ensure that the IDP forms include completed learning and aspiration plans and are in place for all reporting personnel to enable the achievement of goals and capability to assume increased levels of responsibility. Manage the application and communication of all Novo Nordisk policies, procedures, and Novo Nordisk Way.
Qualifications- Bachelor's Degree from an accredited university required and three (3) years of experience in a manufacturing environment required, FDA or other regulated industry preferred
- In lieu of Bachelor's Degree and three (3) years of experience, may consider an Associate's Degree from an accredited college or university and five (5) years of experience in a manufacturing environment required, FDA or other regulated industry preferred
- In lieu of Bachelor's Degree and three (3) years of experience, may consider a High School Diploma or GED and seven (7) years of experience in a manufacturing environment required, FDA or other regulated industry preferred
- Ability to utilize a computer, to include Microsoft Office (Word, Excel, Power Point) required
- Knowledge of cGMP & FDA regulations a plus
- Strong team building, decision-making and people management skills preferred
- Knowledge of business and management principles (budgeting, strategic planning, resource allocation and human resources) preferred
- Familiarity with industry standard equipment and technical expertise preferred
- Experience in an API manufacturing environment preferred