Senior Process Engineer Job at Brightpath Associates LLC, Boca Raton, FL

cytPL3VzSmh0a3BkMW5yd2lEYW1EdXJ2NEE9PQ==
  • Brightpath Associates LLC
  • Boca Raton, FL

Job Description

Job Description

The Senior Process Engineer, Process Development, will play a critical role in supporting the development and transfer of processes for IgG Immunotherapy Production . This position will regularly update the Process Development (PD) Management team to ensure compliance and operational efficiency. Responsibilities include maintaining compliance in the PD laboratory and executing process development, evaluation studies, and process validations using a scale-down model. As a key member of the PD team, this role will support Manufacturing , Quality Control/Assurance , and Regulatory departments.

Key Responsibilities :

  • Provide technical support for issues related to the manufacturing process and product quality .
  • Develop new processes as needed for the production of plasma-derived therapies .
  • Ensure familiarity with regulatory guidelines for process development and validation and implement necessary manufacturing process changes .
  • Optimize and maintain compliance in the PD laboratory by ensuring that all equipment calibration, IQ, OQ, and PM statuses are up to date.
  • Participate in the design and planning of scientific experiments to meet corporate goals for existing projects.
  • Review and/or approve cGMP documentation generated by other members of the PD group as needed.
  • Lead the execution of process development and evaluation studies , as well as process validations using a qualified scale-down model.
  • Oversee the transfer of process changes and/or new processes from PD to Manufacturing.
  • Act as a liaison between PD and Manufacturing to support deviations, investigations, and process transfers.
  • Maintain and review process development batch records for scale-down process models.
  • Perform additional activities as assigned by PD Managers.
  • Support Manufacturing, Engineering, and Quality Management in the development and implementation of new processes and technologies.
  • Assist manufacturing personnel in executing process development and process validation studies within a cGMP production environment.

Education Requirements :

  • Bachelor’s degree in Science, Engineering , or a related field is required.

Experience Requirements :

  • A minimum of 10 years of experience in a cGMP Pharmaceutical/Biological manufacturing environment .
  • Strong familiarity with various aspects of process development and a thorough understanding of FDA cGMP requirements is required.

Job Tags

Similar Jobs

Teva Pharmaceutical Industries Ltd.

Pharmazeut im Praktikum (m/w/d) Pharmacovigilance Job at Teva Pharmaceutical Industries Ltd.

Beginn Mai/Juni 2026 oder auf Anfrage, Dauer 6 Monate ber Teva Teva ist ein global agierender Arzneimittelkonzern und Weltmarktfhrer unter den Generikaunternehmen. Das Herzstck unseres Erfolges sind unsere Mitarbeiter in ber 80 Lndern weltweit. Sie sorgen daf...

V Group Inc.

Lead Java Developer Job at V Group Inc.

 ...~60 months experience developing, implementing and integrating systems related to criminal justice processing at the state or federal level (including but not limited to: disposition processing, fingerprint identification processing, criminal history updating).... 

Onward Search Education

School Social Worker [80358] Job at Onward Search Education

 ...exceptional school district in Van Buren County, MI, to hire a full-time School Social Worker for the 20252026 school year. In this in-person role, the School Social Worker will work to improve the success of students with disabilities in school through service and... 

Grace Federal Solutions LLC

Van Services Driver Job at Grace Federal Solutions LLC

 ...Van Services Driver Evening Shifts Location: North Carolina Employer: Grace Federal Solutions Type: Full-Time | Schedule: Evening shifts with flexibility for weekends and holidays At Grace Federal Solutions , our people are our greatest success. Rooted... 

University of Maryland School of Medicine

Neonatal Nurse Practitioner Job at University of Maryland School of Medicine

 ...The University of Maryland School of Medicine (UMSOM) is seeking a Board-Certified Neonatal Nurse Practitioner (NNP) to join its neonatal practice at UM Capital Region Health in Largo, Maryland. This is an excellent opportunity to work within a Level III NICU alongside...