Senior Process Development Engineer
2 weeks ago
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.
Qualifications
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.
-
Senior Process Engineer, Process Development
22 hours ago
Boca Raton, United States ADMA BIOMANUFACTURING LLC Full timeJob DetailsJob Location ADMA Biologics FL - Boca Raton, FL DescriptionADMA Biologics is a leading biopharmaceutical company dedicated to developing superior therapies for immunodeficient patients at risk of infection. Our unwavering commitment to this underserved population drives us, and our hands-on approach to production and development distinguishes us...
-
Senior Process Development Engineer
2 weeks ago
boca raton, United States Brightpath Associates LLC Full timeJob DescriptionThe 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...
-
Process Engineer I, Process Development
17 hours ago
Boca Raton, United States ADMA BIOMANUFACTURING LLC Full timeJob DetailsLevel Experienced Job Location ADMA Biologics FL - Boca Raton, FL Position Type Full Time Education Level 4 Year Degree DescriptionADMA 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...
-
Senior Network Engineer
1 week ago
Boca Raton, United States iFindTech Ltd Full timeSenior Network Engineer - Boca Raton, Florida, United StatesKey Responsibilities:Network Design and Implementation- Lead the design, deployment, and management of network solutions utilizing Ubiquiti UniFi, Fiber, and LTU technologies.- Develop and implement network architectures that ensure high availability, scalability, and security.- Conduct site...
-
Senior Design Engineer
21 hours ago
Boca Raton, United States Bohler Engineering Full timeOverview At Bohler, we empower the ambitious to become the accomplished. This greater purpose connects us with like-minded professionals, fosters meaningful relationships, and generates the alignment necessary to produce an unrivaled consulting and employment experience. Our Boca Raton, FL office is looking for a Senior Design Engineer who embodies this...
-
Senior Data Engineer
6 months ago
Boca Raton, United States FlexShopper Full timeJob DetailsJob Location Boca Raton - BOCA RATON, FL Position Type Full Time DescriptionCompany Overview: FlexShopper is the largest online lease-to-own marketplace stocked with an incredible selection of products from top brands. When people don't have the cash or credit available, FlexShopper provides the solution - affordable weekly payments so you can...
-
Senior Manager, Software Engineering
4 weeks ago
Boca Raton, United States Modernizing Medicine Full timeWe are united in our mission to make a positive impact on healthcare. Join Us! South Florida Business Journal, Best Places to Work 2024 Inc. 5000 Fastest-Growing Private Companies in America 2024 2024 Black Book Awards, ranked #1 EHR in 11 Specialties 2024 Spring Digital Health Awards, "Web-based Digital Health" category for EMA Health Records (Gold) 2024...
-
Senior Blockchain Engineer
6 days ago
Boca Raton, United States Worxweb Solutions Full timeSenior Blockchain EngineerLocation: Remote or Boca Raton, FLType: Full-Time / ContractCompensation: Competitive, based on experienceAbout UsAt Worxweb Solutions, we are innovators at the intersection of technology and business solutions. We’re working on a groundbreaking project leveraging blockchain to revolutionize how value is exchanged and managed in...
-
Senior Design Engineer
14 hours ago
Boca Raton, United States Bohler Full timeOverview At Bohler, we empower the ambitious to become the accomplished. This greater purpose connects us with like-minded professionals, fosters meaningful relationships, and generates the alignment necessary to produce an unrivaled consulting and employment experience. Our Boca Raton, FL office is looking for a Senior Design Engineer who embodies this...
-
Civil Engineer
4 weeks ago
Boca Raton, Florida, United States Suncoast Drivers Full timeUnlock the future of infrastructure development with Suncoast Drivers as a Civil Engineer - Land Development Specialist!We are seeking a highly skilled and detail-oriented professional to join our dynamic team. If you have a passion for designing and planning innovative, sustainable solutions that transform communities, this is your chance to make a lasting...
-
Manager Analytical Development
2 weeks ago
Boca Raton, United States Brightpath Associates LLC Full timeJob DescriptionThe Analytical Development Manager will support the development of analytical methods and programs for analytical development.QualificationsESSENTIALS OF THE JOB:Responsible for developing new or improved analytical development methods and processesLead project teams and direct reportsIndependently design, execute, analyze studies, under the...
-
Manager Analytical Development
2 weeks ago
Boca Raton, United States Brightpath Associates LLC Full timeJob DescriptionThe Analytical Development Manager will support the development of analytical methods and programs for analytical development.QualificationsESSENTIALS OF THE JOB:Responsible for developing new or improved analytical development methods and processesLead project teams and direct reportsIndependently design, execute, analyze studies, under the...
-
Manager Analytical Development
2 weeks ago
boca raton, United States Brightpath Associates LLC Full timeJob DescriptionThe Analytical Development Manager will support the development of analytical methods and programs for analytical development.QualificationsESSENTIALS OF THE JOB:Responsible for developing new or improved analytical development methods and processesLead project teams and direct reportsIndependently design, execute, analyze studies, under the...
-
Manager Analytical Development
2 weeks ago
boca raton, United States Brightpath Associates LLC Full timeJob DescriptionThe Analytical Development Manager will support the development of analytical methods and programs for analytical development.QualificationsESSENTIALS OF THE JOB:Responsible for developing new or improved analytical development methods and processesLead project teams and direct reportsIndependently design, execute, analyze studies, under the...
-
boca raton, United States iFindTech Ltd Full timeSenior Network Engineer - Boca Raton, Florida, United StatesKey Responsibilities:Network Design and Implementation- Lead the design, deployment, and management of network solutions utilizing Ubiquiti UniFi, Fiber, and LTU technologies.- Develop and implement network architectures that ensure high availability, scalability, and security.- Conduct site...
-
Senior Data Engineer
6 months ago
Boca Raton, United States ModMed Full timeWe are united in our mission to make a positive impact on healthcare. Join Us! South Florida Business Journal, Best Places to Work 2024 Inc. 5000 Fastest-Growing Private Companies in America 2023 Company of the Year | 2023 BIG Innovation Awards Fastest-Growing Company of the Year – Large (Bronze) | 2022 Best in Biz Awards Who we are: ...
-
CEI Senior Project Engineer
4 months ago
Boca Raton, United States APTIM Full timeJob Description Job Description At APTIM, we come to work each day knowing that we are making an impact on the world. Our work spans from safeguarding and maintaining critical infrastructure to helping communities recover from natural disasters, from empowering our armed forces and first responders to reducing carbon and energy use, and from making...
-
Senior Data Engineer
1 week ago
Boca Raton, United States GeniusRx Full timeJob DescriptionJob DescriptionJob SummaryGeniusRx is looking for an experienced data engineer to help bring the next evolution of pharmacy to life. As part of the data science team under product and technology, you will be working together with the data science, engineering, and product teams to ensure the right data gets to the right people. We are building...
-
Senior Windows System Engineer
1 month ago
Boca Raton, United States Atlantic Group Full timeOur client, a prestigious financial service company and alternative investment manager specializing in quantitative investing, is looking to hire a full-time Senior Windows Engineer to work primarily onsite in Boca Raton, Florida!Our Client & What To Expect:The firm trades 24 hours a day, with trades generated automatically in response to changing market...
-
Design Engineer
13 hours ago
Boca Raton, United States Bohler Engineering Full timeOverview At Bohler, we empower the ambitious to become the accomplished. This greater purpose connects us with like-minded professionals, fosters meaningful relationships, and generates the alignment necessary to produce an unrivaled consulting and employment experience. Our Boca Raton, FL office is looking for a Design Engineer who embodies this...