Senior Investigator

Position Title: Sr. Investigator $5,000 Sign on Bonus Monday-Friday 1st shift hours Summary The Sr. Investigator will provide support for Manufacturing Management and Associates to meet batch record review/disposition schedule to adhere to lot release dates. The Sr. Investigator will be responsible for, executing root cause investigations, owning/authoring deviations, driving continuous improvement efforts and other quality report types, and revising GMP documents such as SOPs and Manufacturing batch records. The Sr. Investigator role is critical to our patients. Manufacturing life-saving medicines right the first time with patient safety in mind is our priority. Quality, safety and on-time delivery is a must to be successful in this role! Catalent is a growing Biotech Contract Development and Manufacturing Organization (CDMO) with an internationally recognized tradition of quality and service. Catalent Cell and Gene Therapy provides process development, process characterization, and GMP manufacturing services to industry leaders utilizing novel technologies to produce state-of-the-art vaccines and gene therapies. As a Catalent employee, you will actively contribute to delivery of services to our clients and impact the well-being of their patients. The Role Initiates Quality Records and conducts deviation investigations that meeting both Industry and Catalent expectations Leads or manage investigations including root cause analysis and assesses product impact using input from various departments Develops, executes and oversees CAPAs Technical leadership will be required to ensure that product and process understanding is sufficient to investigate deviations, that investigations are technically sound, meet quality expectations, and that corrective actions are effective. Supports Tech transfer and process monitoring support as needed Works with the team to monitor critical process parameters Revision and management of manufacturing documents such as Batch Records and SOPs Leads or supports Continuous Improvement projects Conducts data gathering, trending, and data presentation as needed to support investigations Responsible for real time, on the floor response in support of operational deviations by gathering information and completing an initial event report. The Candidate Bachelor’s degree in a science or engineering field and 4 years of demonstrated technical competency in biopharmaceutical manufacturing processing in a GMP compliance environment (e.g. Production, Development, Process Engineering, Technical Services or related field) Previous experience operating equipment such as: incubators, single-use bioreactors, depth filtration skids, TFF skids, chromatography skids, single-use mixers and in process testing equipment 3 years of experience in process deviation investigations and remediation Ability to perform interviews and familiarity with root cause analysis Previous experience authoring and/or revising technical documents Ability to support and/or lead system troubleshooting efforts Position Benefits: Opportunity to gain experience in the cutting-edge gene therapy space and help to develop critical lifesaving therapies for our clients 19 days PTO & 8 Holidays Medical, Dental & Vision Benefits and 401k Employee Stock Purchase Plan Tuition Reimbursement 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. Catalent is committed to the health and safety of its employees, visitors and the customers and patients we serve. As a result of the global pandemic, we have modified many of our recruitment and on-boarding processes to maintain everyone’s safety. The Human Resources teams will communicate all necessary safety processes and procedures throughout each stage. personal initiative. dynamic pace. meaningful work. Visit Catalent Careers 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. Catalent = Catalyst Talent Your talents, ideas, and passion are essential to our mission: to develop, manufacture, and supply products that help people live better, healthier lives. Join us! personal initiative. dynamic pace. meaningful work. Catalent is the perfect place to grow your career if… You enjoy the fast pace of a start-up, but want the opportunities and stability of a growing, publicly traded company (Listed on NYSE: CTLT). You want meaningful work. From cough treatments to cancer-fighting drugs, biologics, and vitamins, we help develop, launch, and supply over 200 new products each year – more than any branded drug maker in the world! You want to plant your career in a growing company. Over the last five years, Catalent has re-invested more than $2 billion back into the company and its people. You are excited about learning, collaborating, and growing alongside a global diverse team. Our team of more than 11,000 comes to work every day ready to overcome new challenges with teamwork, advanced technologies, and a passion to deliver by putting patients first. You want to make a global impact! From North America to Europe, Asia to Latin America, we have innovative science and manufacturing teams who are looking for YOU! See how our teams are making a difference, while growing their careers and fulfilling our mission by putting patients first every day here.