Bloomington, IN, 47407, USA
19 days ago
Senior Engineer, Engineering - Process
**Senior Engineer, Process** 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. Catalent’s facility in Bloomington provides a fully integrated and unique model for process development, clinical and commercial mammalian cell culture manufacturing, formulation, parenteral drug manufacturing and packaging under one roof. The award-winning facility provides clinical and commercial bulk drug substance and drug product manufacturing, including liquid and lyophilized vials, and prefilled syringes, along with an array of support services. **The Senior Engineer, Process** **is responsible for overseeing and optimizing manufacturing processes related to the production, inspection and packaging of sterile biologic drug products. Designing, implementing, and improving manufacturing processes. The Process Engineer 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 position will further assist in the management and planning of project budgets and schedules and provide contractor oversight.** **This is a fulltime, onsite role, working days; Monday – Friday.** **This role offers a sign on bonus of $10,000** 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** + Serve as a SME (Subject Matter Expert) on more than one validated system and at least one technical field + 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. + Collaborate with cross-functional teams, including manufacturing and quality assurance to support product commercial manufacturing activities. + Manage installation/operational qualification (IQ/QQ) of various systems/equipment + Drive continuity and development of standards in Project Engineering to ensure smooth and effective communication flow between internal resources and customers, operational efficiency, and equipment and personnel safety **The Candidate** + Bachelor's degree in Chemical/Mechanical/Electrical Engineering or appropriate scientific discipline, with 5-8 years of relevant experience, required + Master’s degree, preferred + Serialization processes and data flow experience with knowledge of TraceLink/SAP ATTP, preferred + 5+ years Project Engineering relevant experience, preferred + 2+ years within the pharmaceutical or biotechnology industry with a focus on sterile biologics manufacturing, inspection and/or packaging, preferred + Highly skilled and/or certified in multiple trades + 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 Processes **Catalent 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 Catalent Careers (https://careers.catalent.com/us/en) 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 DisabilityAccommodations@catalent.com . 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 HERE (https://cdn.catalent.com/files/legal/CCPA-Privacy-Notice-at-Collection-for-California-Employees-and-Applicants-English.pdf) .
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