Process Engineer II, Process Development

Process Engineer II, Process Development

ADMA Biologics is a biopharmaceutical company relentlessly committed to creating superior products for immunodeficient patients at risk for infection. It is our devotion to this underserved population that fuels us and our hands‑on approach to production and development that sets us apart. If you are looking for a dynamic, innovative, growing company in the biopharmaceutical industry that is committed to excellence and integrity, then consider ADMA Biologics.

The Process Engineer II provides process development and transfer expertise for IgG Immunotherapy Production. Provides updates to Process Development (PD) Management team on a regular basis to ensure compliance issues are being met. Responsible for maintaining compliance in PD laboratory and executing process development/evaluation studies as well as process validations using a scale down model. As a key member of the PD group, provides support for Manufacturing, Quality Control/Quality Assurance, and Regulatory departments.

The standard schedule for this position is 8:00 AM to 5:00 PM, but employees may occasionally be required to work 12‑hour rotating shifts during operational campaigns and manufacturing model runs.

• Provide support for technical issues related to the manufacturing process and product quality.
• Develop new processes as required for production of plasma‑derived therapies.
• Be familiar with regulatory guidelines for process development/validation as well as implementing manufacturing process changes.
• Optimize and maintain compliance in PD laboratory by ensuring all equipment calibration/IQ/OQ/PM status are current.
• Design and plan scientific experiments to achieve corporate goals for existing projects. Write protocols and reports in support of PD studies.
• Review and/or approve cGMP documentation generated by other PD group members as necessary.
• Lead execution of process development/evaluation studies as well as process validations using a qualified scale down model.
• Be responsible for transferring process changes and/or new processes from PD to Manufacturing.
• Act as a liaison between PD and Manufacturing for supporting deviations and investigations as well as when transferring new and/or optimized processes.
• Maintain and review process development Batch Records for scale down process models.
• Perform other activities as assigned by the PD Managers.
• Support Manufacturing, Engineering, and Quality Management departments with the development and implementation of new process/technology.
• Assist manufacturing personnel in the execution of process development and process validation studies in cGMP production environment as necessary.

Competencies

• Ability to follow cGMP procedures with great attention to detail.
• Ability to work in a high‑pressure, deadline‑driven environment.
• Demonstrated ability to achieve goals, overcome obstacles, and meet deadlines.
• Possess time management skills and be able to balance multiple job assignments at once.
• Possesses excellent oral and written communication skills with close attention to detail and accuracy to collaborate effectively with cross‑functional teams and communicate findings and recommendations.

• Education:
  
  Bachelor’s degree in Science or Engineering required.
• Minimum of five (5) years of experience in a cGMP, pharmaceutical/biological manufacturing environment.
• Familiarity with many aspects of process development is expected.
• Knowledge of FDA cGMP requirements is required.

No specific preferred experience listed.

The minimum compliance expectation for this role entails strict adherence to FDA regulations and company policies governing sales and marketing activities. This includes completion of required compliance training, accurate documentation of sales interactions, and adherence to data privacy regulations. Additionally, the role requires proactive participation in compliance reviews, prompt reporting of any potential issues, and ongoing education to stay updated on relevant FDA regulations.

• 401(k) plan with employer match and immediate vesting.
• Medical, vision, life and dental insurance.
• Pet insurance.
• Company‑paid short‑term and long‑term disability.
• Company‑paid holidays.
• 3 weeks’ paid time off (within the first year).
• Tuition assistance (after the first year).
• Easily accessible to Tri‑Rail.
• Free shuttle to the Boca Tri‑Rail station.

ADMA Biologics is an Equal Opportunity Employer.