Specialist I, Manufacturing Technical Operations

　　POSITION SUMMARY

　　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 Specialist I, Manufacturing Technical Operations (MTO) will provide support to Manufacturing Associates to meet batch record review/disposition schedule to adhere to lot release dates. The Specialist I, MTO will be responsible for, executing root cause investigations, owning/authoring deviations, driving continuous improvement efforts and other quality reports and revising GMP documents such as SOPs and Manufacturing batch records.

　　This is a full-time role working days; Monday – Friday

　　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

　　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.

　　Assist in the revision and management of manufacturing documents such as Batch Records and SOPs

　　Supports Continuous Improvement projects

　　Conducts data gathering, trending, and data presentation as needed to support investigations

　　Other duties as assigned

　　The Candidate

　　Masters’ degree in a Scientific, Engineering or Biotech field with 2 years’ experience in biopharmaceutical manufacturing processing in a GMP compliance environment (e.g. Production, Development, Process Engineering, Technical Services or related field) OR

　　Bachelor’s degree in a Scientific, Engineering or Biotech field with 3 years’ experience in biopharmaceutical manufacturing processing in a GMP compliance environment (e.g. Production, Development, Process Engineering, Technical Services or related field) OR

　　Associate’s Degree or HS Diploma with 4-6 years’ experience in biopharmaceutical manufacturing processing in a GMP compliance environment (e.g. Production, Development, Process Engineering, Technical Services or related field)

　　Knowledge of GMP’s, FDA regulations and documentation procedures, required

　　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 a plus

　　Previous experience in process deviation investigations, including minor and/or major deviations

　　Excellent communication and technical writing skills

　　Familiar with Lean Six Sigma Methodologies and proven analytical/ problem solving capabilities

　　Creative thinking with the ability to multi-task

　　Commitment to ongoing professional development

　　Team player who thrives in collaborative environments and revels in team success

　　On-site presence, as the role requires time on the manufacturing floor and cross-functional collaboration

　　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.

　　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 (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 [email protected] . 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 [email protected] 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) .