Process Engineer - Aseptic Filling

Company: Disability Solutions
Location: Bloomington
Posted on: September 4, 2024

Job Description:

Process Engineer - Aseptic FillingCatalent 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.--Catalent Pharma Solutions in Bloomington, Indiana is a state-of-the-art, GMP manufacturing facility, providing one million sq/ft of drug substance manufacturing, drug product manufacturing, and related pharmaceutical services. This award-winning facility helps customers accelerate biologic drug development programs and bring better treatments to help patients live better healthier lives.Catalent is hiring a Process Engineer at the Bloomington Indiana site. This role is responsible for overseeing and optimizing manufacturing processes related to the production of sterile biologic drug products. Designing, implementing, and improving manufacturing processes.The Process Engineer - Aseptic Filling will support ongoing activities by assisting in troubleshooting mechanical problems, process problems and identifying improvements in operations to minimize interruptions maximize utilization and supporting new and ongoing projects. This is a fulltime role working days; Monday - FridayThis role offers a sign on bonus of $5,000 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

• Optimize manufacturing processes to produce sterile manufacturing, including upstream and downstream processes while focusing on isolation technologies.
• Design and implement process improvements to enhance product quality, yield, and efficiency.
• Perform process risk assessments.
• Collaborate with cross-functional teams, including manufacturing and quality assurance to support product commercial manufacturing activities.
• Lead investigations into process deviations, identify root causes, and implement corrective and preventive actions.
• Participate in technology transfer activities to ensure smooth transfer of processes from development (PPQ) to manufacturing.
• Develop process documentation such as standard operating procedures (SOPs), protocols and other similar GMP documents.
• Provide technical support, oversight and training to manufacturing personnel to ensure proper execution of manufacturing processes.
• Contribute to the design and qualification of manufacturing equipment and isolator systems.
• Optimize steam sterilization processes for various applications utilizing "clean steam' for the purposes of steam in place, sterilization of filling equipment and terminal sterilized product.
• Conduct studies and risk assessments to identify potential hazards and mitigation strategies.
• Cross-functional collaboration, including R&D, quality assurance, and manufacturing, to integrate sterilization processes into product development and production.
• Troubleshooting sterilization equipment and processes to ensure efficient operation and minimal downtime.
• Analyze process data to identify trends, optimize performance, and drive continuous improvement initiatives.
• Technical expertise in and support to ensure compliance with industry standards and regulatory requirements, such as FDA, ISO, and cGMP.
• Participating in validation activities, including IQ/OQ/PQ protocols, to ensure the effectiveness and reliability of sterilization processes.
• Training and mentoring shop floor employees steam sterilization, VHP sterilization cycles, in process critical parameters, isolator, sterilizer, lyophilization (Lyo) testing, equipment cycles, and filter integrity principles.The Candidate:
  • Bachelor's degree in Chemical/Mechanical/Electrical Engineering or appropriate scientific discipline, required, or 8 years of engineering experience in lieu of the degree
  • PE / Registered Engineer in training, preferred
  • OSHA 10 or equivalent a plus, preferred
  • 2+ years of Project Engineering related experience
  • Strong understanding of cGMP regulations, FDA guidelines, and industry standards related to sterile manufacturing.
  • Excellent problem-solving skills and the ability to troubleshoot complex manufacturing issues.
  • Strong communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams.
  • Detail-oriented approach with a commitment to quality and compliance.
  • Must be able to read and understand English-written job instructions and safety requirements--Why you should join Catalent:
    • Competitive medical benefits and 401K
    • 152 hours of PTO + 8 Paid Holidays
    • Dynamic, fast-paced work environment
    • Opportunity to work on Continuous Improvement ProcessesCatalent 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, Bloomington , Process Engineer - Aseptic Filling, Engineering , Bloomington, Indiana