Manufacturing Principal Investigator II

American Regent

New Albany, OH

Nature and Scope

As a member of the Manufacturing department, the Principal Investigator II ensures any non-routine events associated with the manufacture of safe, pure, and effective sterile pharmaceuticals are investigated and documented in accordance with company SOPs, policies, and cGMPs. This is a cross-functional position that interacts with Quality Systems, Manufacturing, Materials Management, Maintenance and QC-Microbiology.

This position generates investigation summaries for all departments within the facility and may include data compilation and evaluation, impact assessments, root cause analyses, and corrective/preventive actions. The Principal Investigator II also has responsibilities in the data entry, generation and evaluation of process and performance metrics. The Principal Investigator II also has a critical role in maintaining production schedules and meeting Company goals.

Essential Duties and Responsibilities

Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time.

  • Ensure event and deviation timelines are maintained through inter-department communication.
  • Able to handle more challenging, in-depth investigations utilizing more advanced investigational tools while still maintaining the high level of quality.
  • Manages open CAPAS associated with manufacturing.
  • Able to speak to/defend positions on documents submitted by facilities.
  • Helps drive changes in processes/procedures. Able to assist the manufacturing team in submitting change controls, investigations, CAPAS, etc.
  • Periodically summarize and present on-going process and performance metrics.
  • Gown and enter aseptic manufacturing to support investigations.
  • Attends all training programs as required by Company SOPs, procedures and policies.
  • Perform any other tasks/duties as assigned by management.

Education Requirements and Qualifications

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.

  • Bachelor’s degree preferred.
  • Minimum 2 years’ experience in a professional setting required.
  • Work experience in an FDA regulated environment is preferred.
  • Experience investigating issues that may occur during cGMP manufacturing of commercial drug product and summarizing any investigations in written format preferred
  • Must be able to work independently with minimal supervision.
  • Intermediate skills in MS Word and MS Excel are required; experience with MS Visio, and MS Access preferred.
  • Must be able to work independently and recognize what daily needs to be met with minimal supervision.
  • Possesses excellent oral and written English communication and comprehension skills.
  • Technical writing and problem solving skills preferred
  • Ability to perform basic mathematical calculations.
  • Ability to take feedback constructively and function in a team oriented work environment.
  • Ability to work overtime as needed.

Physical Environment and Requirements

  • Physically able to wear cleanroom/protective gowning and equipment, including but not limited to gowning, goggles, face shields, respirators, and protective gloves. PPE and Respirators are essential for the health and safety of employees.

American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status.

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