Product Development Engineer II

Company: Disability Solutions
Location: Chelsea
Posted on: November 16, 2024

Job Description:

Product Development Engineer II Position Summary:Catalent is a global, high-growth, public company and a leading partner for the pharmaceutical industry in the development and manufacturing of new treatments for patients worldwide. Your talents, ideas, and passion are essential to our mission: to help people live better, healthier lives.--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 Product Development Engineer II is to actively participate in the development of pharmaceutical processes, technology transfers, and scale-up of spray-drying, particle size reduction, blending and capsule filling unit operations. An individual at the level of Engineer II will be expected to understand and execute setup, operation, troubleshooting, breakdown, and cleaning of designated small scale and pilot scale pharmaceutical manufacturing equipment under limited supervision. This job role is also responsible to lead the transfer of processes to the GMP manufacturing team.This is a full time, salaried role. The core hours are Monday - Friday - days. 8:00-5:00PM Catalent is committed to a Patient First culture through excellence in quality and--compliance, and to the safety of every patient, consumer, and Catalent employee.--The Role

• Supports product and process development activities and is responsible to lead set-up and execution experiments on development non-GMP manufacturing equipment;
• Participates in technology transfer of processes from internal and external partners;
• Conducts readiness activities and documentation preparation for GMP development and clinical manufacturing and participates in execution as required;
• Performs analysis of experimental data and interprets results with guidance from senior team members; --
• Contributes written and visual content for development reports and makes recommendations for future development work based on results;
• Provides training to manufacturing operations team for new processes and oversees execution of critical manufacturing steps;
• Provides technical support to other areas including formulation development, analytical development, manufacturing, engineering, and quality; --
• Ability to effectively manage time and prioritize tasks with guidance to meet tight timelines and shifting priorities;
• Demonstrates dedication to documentation/data traceability with strong attention to detail and clarity of communication;
• All other duties as assignedThe Candidate
  • Bachelor's degree or higher in Chemical Engineering, Biomedical engineering, Mechanical engineering, Pharmaceutical Sciences or related technical field required;
  • A minimum of 1+ years of relevant experience required;
  • Experience working in an FDA regulated operation preferred;
  • Prior experience with spray drying or solid dosage manufacturing preferred but not required;
  • Familiarity with statistical data analysis utilizing Excel, JMP, Minitab, or equivalent;
  • Strong written and verbal communication skills at a variety of technical levels;
  • Ability to apply scientific and engineering fundamentals to breakdown complex problem statements;--
  • Individual may be required to sit, stand, walk regularly and occasionally lift 0-15 pounds;Why you should join Catalent:
    • 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 categoriesCatalent offers rewarding opportunities to further your career!-- Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.--personal initiative. dynamic pace. meaningful work.Visit to explore career opportunities.Catalent is an Equal Opportunity Employer, including disability and veterans.If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to . This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.--------Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.Important Security Notice to U.S. Job Seekers:Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond- it is a fraudulent request. Please forward such requests to spam@catalent.com for us to investigate with local authorities.California Job Seekers can find our California Job Applicant Notice .

Keywords: Disability Solutions, Waltham , Product Development Engineer II, Engineering , Chelsea, Massachusetts