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Senior Process Engineer, Manufacturing Sciences (Flex)

Company: Catalent Inc
Location: Madison
Posted on: May 26, 2023

Job Description:

Job Title: Senior Process Engineer, Manufacturing Sciences (Flex)
City: Madison
State : WI
Act as part of the Manufacturing Sciences group to support the transfer, execution, and monitoring of mRNA and novel processes in our manufacturing suites. Support the site's strategic plan by working with Consultants, Manufacturing and Quality personnel to manage the deliverables required to prepare the Madison, WI site for early Phase and Phase III/Commercial manufacturing. Support the tech transfer, scale up, and process documentation required to transfer Phase I-III/Commercial processes from Process Development into Manufacturing or external transfer programs. Manage specific client requests and attend client meetings. Support the Program Managers and Commercial Readiness Team and close process gaps or improvements.

  • Use comprehensive knowledge of principles, concepts and practices and/or techniques to lead complex projects within department and cross functionally

  • Apply technical and functional knowledge to design experiments or projects that contribute to overall direction of department

  • Routinely suggest new, innovative solutions to routine and complex problems

  • Risk mitigation and prediction

  • Recommend process scale-up of biological processes, lead gap analyses to identify key process parameters and equipment needs to facilitate process transfer into manufacturing.

  • Support technology transfer process (both internal and external) to support both clinical and late phase production.

  • Support the authoring of process descriptions and batch records, support equipment, commissioning, process training, and validation activities.

  • Lead facility fit activities for existing and future internally and externally transferred processes.

  • Perform duties to improve clinical and commercial production processes for the manufacturing group.

  • Act as subject matter expert for equipment and process troubleshooting.

  • Author and lead change controls and investigations.

  • Perform all of the foregoing in a current Good Manufacturing Practices (cGMP) environment with progressive responsibilities for commercial biopharmaceutical manufacturing, applying knowledge of mRNA process, chromatography, and filtration, writing and reviewing standard operating procedures and batch production records, and support and lead deviation investigations, operating, maintaining, and troubleshooting disposable stirred vessel bioreactors.

    EDUCATION AND EXPERIENCE : Requires a Master's degree in Chemical Engineering, Biochemical Engineering or Related Field and 4 years of experience in the job offered or 4 years of experience in the Related Occupation. Experience can be pre or post degree.
    Sr. Associate/Associate or any other job title performing the following job duties:
    Process Troubleshooting & Support:
    Using chemical engineering principles (e.g. reaction operations, fluid flow, heat and mass transfer, pressure and temperature control systems, and general chemical/separation operations, etc.) to maintain process reactions and other unit operations related to impurity removal
    Training and mentoring peers and/or operators to ensure sufficient knowledge of manufacturing processes to execute daily tasks safely and effectively while driving process improvement opportunity to increase productivity, and other continuous improvement initiatives (e.g. yield, waste reduction, etc.)
    Equipment Troubleshooting:
    Applying knowledge of equipment design and principles on which they operate (e.g. reactors, pumps, separation columns, sensors, controllers associated with flow, pressure and temperature) to identify and/or resolve problems when they arose and coordinate with maintenance and technical department such that impact to operations due to equipment downtime can be minimized
    Authoring or providing key SME input into documentation associated with process execution operating procedures and instructions, shift reports, protocols, and reports related to, change over procedures, equipment maintenance activities, or investigations.
    Leading and/or co-leading projects or activities for shift operations ensuring the assigned tasks are completed timely and accurately without any delays while focusing on yield and quality production targets.
    JOB TIME : Full Time
    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 . 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 for us to investigate with local authorities.
    California Job Seekers can find our California Job Applicant Notice HERE ( .

Keywords: Catalent Inc, Madison , Senior Process Engineer, Manufacturing Sciences (Flex), Engineering , Madison, Wisconsin

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