Process Development Engineer
About The Position
Process Development Engineer I Position Summary: Work Schedule: Monday – Friday from 8am-5pm, overtime as needed depending on production 100% on-site (Chelsea, MA) Catalent, Inc. is a leading global Contract Development and Manufacturing Organization (CDMO), and the Boston-area facility is Catalent’s global Center of Excellence for spray dry dispersion and Dry Powder Inhaler (DPI) capsule manufacture and packaging. The site features inhaled powder spray drying, as well as multiple commercial-scale lines for capsule filling and blister packaging. On-site spray dryers include best-in-class GEA Niro SD1, SD4 and SD7, the latter being the largest CGMP unit of its kind for DPI in North America. Catalent Pharma Solutions is hiring a Process Development Engineer who will actively participate in the development of pharmaceutical processes, technology transfers and scale-up of spray-drying, secondary drying, capsule filling, and capsule blistering processes. You will support Good Manufacturing Practices (GMP) clinical and non-GMP development manufacturing, particularly for dry-powder inhalation products. This person is also responsible for transferring the process to commercial manufacturing and providing recommendations for a successful scale-up and transfer. You will be a key member of troubleshooting manufacturing issues at any stage of development.
Requirements
- Bachelor’s Degree in Chemical, Biomedical Engineering or Pharmaceutical Sciences (or related field) required. Master’s Degree is a plus
- Must have at least one (1) year of relevant industry experience (defined below), preferably in biotechnology/pharmaceutical R&D
- Prior experience with dry powders for inhalation, specifically in the areas of particle engineering of dry powders, blending and capsule filling
- Strong statistical background with knowledge of Design of Experiments (DoE) preferred. Knowledge of Quality by Design, cGMP and modelling is a plus
- Must be proficient in Microsoft Office Suite. Minitab or JMP is a plus
- Ability to effectively manage time and prioritize tasks independently to meet tight timelines and shifting priorities
- Physical requirements: Individual may be required to sit, stand, walk regularly and occasionally lift 0-40 pounds
Nice To Haves
- Master’s Degree is a plus
- Knowledge of Quality by Design, cGMP and modelling is a plus
- Minitab or JMP is a plus
Responsibilities
- Responsible for the start-up, troubleshooting and process development of late phase tech transfer, scale-up and pre-commercial manufacturing
- Supports process development activities and is responsible to set-up and run experiments on GMP manufacturing equipment
- Conducts analysis of development data and provides recommendations for future experimental designs
- Participates in the assembly, operation, disassembly and cleaning of equipment. Assists manufacturing operations with validation of new processes as needed
- Responsible for the evaluation of critical process data and drives the process development life-cycle
- Provide technical support to other areas including spray drying, secondary drying, process engineering, QC, and QA
- Understand Quality by Design approaches and conduct modeling exercises to better understand process development. Manages and coordinates individual projects (internal and external) as needed
- All other duties as assigned
Benefits
- Defined career path and annual performance review and feedback process
- Diverse, inclusive culture
- Positive working environment focusing on continually improving processes to remain innovative
- Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives
- 152 Hours + 8 paid holidays
- Several Employee Resource Groups focusing on D&I
- Dynamic, fast-paced work environment
- Community engagement and green initiatives
- Generous 401K match
- Company match on donations to organizations
- Medical, dental and vision benefits effective day one of employment
- Tuition Reimbursement – Let us help you finish your degree or start a new degree!
- WellHub program to promote overall physical wellness
- Perkspot - offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Entry Level
