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Supervisor, Production Operations – Grafton, WI

Curia provides global contract research and manufacturing services to the pharmaceutical and biotechnology industries.

The Supervisor, Production Operations will be responsible for the planning of daily manufacturing activities per the weekly production calendar. This role is also responsible for the completion of assignments needed to execute a dynamic production schedule within the clean room cGMP facility. The Supervisor will work with cross-functional departments to complete assignments in a fast-paced and dynamic environment.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Join our talented workforce, where a commitment to excellence and a customer focused attitude is everything. We pursue excellence because our work has the power to improve patients’ lives with the pharmaceuticals we develop and manufacture.

Supervisory Responsibilities

This position does have supervisory responsibilities.

Essential Job Duties

• Coordinate the activities of a work team, which may consist of several Manufacturing Technicians and provide expertise for the specific technical area

• Train and develop junior staff on aseptic technique and filling machine operation

• Perform and train aseptic processing operations and serve as the lead operator in these activities

• Provide leadership, in the absence of the department/shift manager

• Work with management on team performance management, including annual reviews, disciplinary actions, training status, employee development plans, and succession planning

• Escalate any non-conforming events to the appropriate cross-functional stake holder

• Function independently or in a larger cross functional group

• Plan, oversee and participate in projects as necessary based on the department needs

• Operate, troubleshoot and maintain manufacturing equipment and see through the maintenance process using work orders

• Ensure direct reports maintain 100% up to date on their training curricula

• Conduct, coordinate and document quality/safety incidents and investigations, corrective and preventive actions (CAPAs)

• May establish and maintain systems to track department deliverables and trend performance against metrics

• Ensure the cleanroom is equipped with the necessary materials, tools and equipment necessary. Will order supplies and issue work orders as needed

• Own, review, and approve complex manufacturing documents and records to ensure they comply with CGMPs and internal quality system requirements

• Work with Engineering, Materials Management, Quality Assurance and Validation to complete assignments, and ensure ongoing continuous improvement

Requirements

• High school or equivalent

• Minimum 5 years’ experience in pharmaceutical manufacturing, including 1 year in a leadership role

Preferred

• Associate’s or Bachelor’s degree or biotechnology certificate

• Previous cleanroom or cGMP experience

• Supervisory experience strongly preferred

• Experience in the field in lieu of certificate program may be considered

• Advanced degree in related field may be considered in lieu of experience

Knowledge, skills and abilities

• Fill/finish or aseptic technique training strongly preferred

• Ability to become fluent in all functional areas Ability to pass sterile gowning qualification required

• Excellent communication skills

• Desire to work collaboratively with clients, vendors, and supporting departments

• Must be versatile with strong prioritization skills

• Ability to delegate tasks appropriately to a wide range of skilled technicians and function

• Comprehensive understanding of cGMP compliance and proficiency with Windows-based Microsoft Office applications is a requirement

Physical Requirements

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to sit; use hands to finger, handle, or feel; and talk or hear. The employee frequently is required to reach with hands and arms. The employee is occasionally required to stand; walk; climb or balance; and stoop, kneel, crouch, or crawl. The employee must occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, and ability to adjust focus.

Work Environment

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee has the potential of being exposed to fumes or airborne particles and toxic or caustic chemicals (wearing proper Personal Protective Equipment will be required in these situations). The employee is occasionally exposed to wet and/or humid conditions; moving mechanical parts; high, precarious places; outside weather conditions; and may be expected to work with electronic equipment (always being aware of one’s environment and taking proper precautions is required). The noise level in the work environment is usually moderate.

Employee may be responsible for moving and/or generating hazardous waste for treatment, storage and disposal. Affected employee will need to be familiar with the applicable training requirements included in the customized Resources, Conservation and Recovery Act. Employee will understand waste labeling, secondary containment, chemical compatibility, storage time limits, container size and quantity limits, container integrity when waste is left unattended and improper disposal of hazardous materials.

The above statements are intended to describe the general nature and level of work performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of all job duties performed by the personnel as classified. Management reserves the right to revise or amend duties at any time.

All interested applicants must apply online. Curia is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

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