Senior Process Engineer, Process Development
1 month ago
Job Location
ADMA Biologics FL - Boca Raton, FL
Position Type
Full Time
Education Level
4 Year Degree
Description
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. We currently have an exciting opportunity available for a Senior Process Engineer, Process Development in Boca Raton, Florida.
The Senior Process Engineer, Process Development will provide process development and Transfer support for IgG Immunotherapy Production. Provide 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 provide support for Manufacturing, Quality Control/Quality Assurance, and Regulatory departments.
Qualifications
- 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 to 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.
- Participate in designing and planning scientific experiments to achieve corporate goals for existing projects.
- 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.
Bachelor's degree in Science, Engineering, or a related field is required.
Experience Requirements:
A minimum of ten (10) years of experience in a cGMP, Pharmaceutical/Biological manufacturing environment is required. Familiarity with many aspects of process development is required. Knowledge of FDA cGMP requirements is required.
In addition to competitive compensation, we offer a comprehensive benefits package including:
- 401K plan with employer match and immediate vesting
- Medical, Vision, Life and Dental Insurance
- Pet Insurance
- Company paid STD and LTD
- 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 uses E-Verify to confirm the employment eligibility of all newly hired employees. To learn more about E-Verify, including your rights and responsibilities, please visit www.dhs.gov/E-Verify.
ADMA Biologics is an Equal Opportunity Employer
-
Scientist II Process Development
1 week ago
Boca Raton, United States ADMA Biologics Full timeJob DetailsLevel ExperiencedJob Location ADMA Biologics FL - Boca Raton, FLPosition Type Full TimeEducation Level 4 Year DegreeJob Category PharmaceuticalDescription ADMA Biologics is a leading biopharmaceutical company dedicated to developing superior products for immunodeficient patients at risk of infection. Our unwavering commitment to this underserved...
-
Scientist II Process Development
2 months ago
Boca Raton, United States ADMA Biologics Full timeJob DetailsLevel ExperiencedJob Location ADMA Biologics FL - Boca Raton, FLPosition Type Full TimeEducation Level 4 Year DegreeJob Category PharmaceuticalDescription 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...
-
Senior Land Development Engineer
3 days ago
Boca Raton, Florida, United States Bohler Full timeAbout the RoleWe are seeking a highly skilled Senior Land Development Engineer to join our team at Bohler. As a key member of our team, you will be responsible for collaborating with our experts to work on challenging land development projects in a fast-paced environment.Key ResponsibilitiesCollaborate with team members to design site plans for top brand...
-
Senior Reliability Engineer
2 months ago
Boca Raton, United States beBee S US Full timeJob Details Job Location ADMA Biologics FL - Boca Raton, FL Description 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...
-
Business Process Analyst in FinTech
2 weeks ago
Boca Raton, Florida, United States FlexShopper Full timeLocation: Local candidates preferred - Onsite 5 days a week.Join a dynamic and innovative FinTech and eCommerce organization that specializes in providing high-quality durable goods to consumers through a lease-to-own (LTO) model via its online marketplace. Our company also empowers retailers and e-tailers with advanced LTO technology platforms, enabling...
-
Senior Project Engineer
2 weeks ago
Boca Raton, United States Gpac Full timeSenior Project Engineer (Commercial Concrete)Location: Fort Lauderdale Job Type: Full-TimeCompany Overview: A premier construction firm specializing in commercial concrete projects. We are known for our commitment to excellence and innovation in the industry. We are currently seeking an experienced Senior Project Engineer with a strong background in...
-
Senior Structural Engineer, PE
2 months ago
Boca Raton, United States Trilon Group Full timeSenior Structural Engineer, PEDepartment: Transportation Employment Type: Full Time Location: Boca Raton, FL Reporting To: Megan Mott Description We're looking for a Senior Structural Engineer to join the DRMP team! Your Primary Responsibilities will include Develop structural calculations and produce engineering drawings for both Design-Bid-Build and...
-
Senior Civil Engineering Specialist
2 weeks ago
Boca Raton, Florida, United States Suncoast Drivers Full timeJob Overview Join Suncoast Drivers as a Senior Civil Engineering Specialist and play a pivotal role in advancing our infrastructure initiatives. If you are dedicated to crafting, developing, and implementing innovative solutions that enhance community living, this opportunity is designed for you. We are in search of a skilled professional who is eager to...
-
Senior Data Engineer
2 weeks ago
Boca Raton, Florida, United States AgileEngine Full timeAbout AgileEngineAgileEngine is a leading provider of custom software solutions, recognized as one of the Inc. 5000 fastest-growing companies in the US and a top-3 ranked dev shop according to Clutch. We create award-winning software solutions that help companies across various industries transform their businesses.Job DescriptionWe are seeking a highly...
-
Senior Manager, Structural Engineering
3 weeks ago
Boca Raton, United States SBA Communications Full timeSBA Communications is a leading independent owner and operator of wireless communications infrastructure, including towers, buildings, rooftops, DAS and small cells. We offer a competitive benefits and compensation package and are looking for team members who will thrive in our dynamic environment.We welcome your interest in SBA. Let us know a little about...
-
Senior Manager, Structural Engineering
3 weeks ago
Boca Raton, United States SBA Communications Full timeSBA Communications is a leading independent owner and operator of wireless communications infrastructure, including towers, buildings, rooftops, DAS and small cells. We offer a competitive benefits and compensation package and are looking for team members who will thrive in our dynamic environment. We welcome your interest in SBA. Let us know a little about...
-
Senior Structural Engineering Supervisor
2 weeks ago
Boca Raton, Florida, United States SBA Communications Full timeSBA Communications is a prominent independent proprietor and operator of wireless communications infrastructure, encompassing towers, buildings, rooftops, DAS, and small cells. We provide a competitive benefits and compensation package and seek team members who will excel in our dynamic environment. We invite your interest in SBA. Please share a bit about...
-
Senior Manager, Structural Engineering
1 month ago
Boca Raton, United States SBA Communications Full timeSBA Communications is a leading independent owner and operator of wireless communications infrastructure, including towers, buildings, rooftops, DAS and small cells. We offer a competitive benefits and compensation package and are looking for team members who will thrive in our dynamic environment. We welcome your interest in SBA. Let us know a little about...
-
Senior Data Engineer
3 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 Site Reliability Engineer
3 weeks ago
Boca Raton, United States ADT Full timeJob DescriptionThis is a hybrid role based out of ADT's Corporate HQ in Boca Raton, FL. Alternative locations are Irving, TX and Blue Bell, PA. Employees must be in the office a minimum of three days per week.What You'll Do: ADT's Site Reliability Engineering (SRE) team is looking for a passionate software engineer who wants their lines of code to have a...
-
Compensation Processing Specialist
2 weeks ago
Boca Raton, Florida, United States Better Car People Full timeJob OverviewPosition Title: Payroll AdministratorPosition Summary: We are looking for a meticulous and highly organized Payroll Administrator to become a part of our finance department. The Payroll Administrator will oversee all facets of payroll management, ensuring precise and timely calculation, documentation, and verification of employee earnings. The...
-
Product Development Engineer
3 days ago
Boca Raton, Florida, United States ASR GroupDomino Sugar Full timeJob SummaryWe are seeking a highly skilled Product Engineer to join our team at ASR Group/Domino Sugar. As a Product Engineer, you will play a critical role in the design and development of new products, ensuring they meet the highest standards of quality and performance.Key ResponsibilitiesDesign and develop new products using computer-aided design (CAD)...
-
Senior Software Engineer
1 month ago
Boca Raton, United States Material Bank Full timeJob DescriptionJob DescriptionMaterial Bank is a fast-paced, high-growth technology company and created the world's largest material marketplace for the Architecture and Design industry, providing the fastest and most powerful way to start and manage a design project. Learn more about us at www.materialbank.com or see below.--Join our innovative team as...
-
Senior Engineer
3 months ago
Boca Raton, United States Engineering Solutions Full timeJob Title: Senior Structural Professional EngineerJob Location: Based in West Palm, FloridaRequirements: 5+ years of recent Residential/Commercial Design Experience & Active PE LicenseEngineering Solutions is an established firm specializing in new and existing commercial projects and custom residential design. We’re seeking an individual who is willing...
-
Senior Engineer
3 months ago
Boca Raton, United States Engineering Solutions Full timeJob Title: Senior Structural Professional EngineerJob Location: Based in West Palm, FloridaRequirements: 5+ years of recent Residential/Commercial Design Experience & Active PE LicenseEngineering Solutions is an established firm specializing in new and existing commercial projects and custom residential design. We’re seeking an individual who is willing...