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Senior Process Engineer

About Catalent San Diego

Catalent San Diego, Inc. (Formerly Pharmatek Laboratories, Inc.) is a premier pharmaceutical chemistry development and manufacturing organization supporting the pharmaceutical and biotechnology industries. Catalent San Diego focuses on bringing client drug compounds from discovery to the clinic with services that include analytical development, preformulation testing, formulation development, GMP manufacturing and stability storage and testing.

At Catalent San Diego, we recruit and develop exceptional individuals with a passion for science and determination to excel. We offer a technically challenging and stimulating environment and the opportunity to learn from the best. We provide a generous benefits package, on-site gym and fitness programs, team sports, activities and competitive compensation.

Process Engineer III Summary

An individual at the level of Process Engineer III will be expected to understand and execute operation of small scale and pilot scale pharmaceutical manufacturing equipment without supervision.  Duties will include the evaluation of formulation and process procedures to determine their effects in relation to final product specifications.  This will include evaluating equipment set points and process procedures for their impacts on final product characteristics. Duties include participation in formulation process evaluation for demonstration batch productions prior to cGMP manufacturing with the lead chemist, without supervision.  This may include recommendations for formulation excipient selection and final product attributes critical to process automation.  The Process Engineer III will also lead the project risk assessments, with Pharmaceutics and Manufacturing personnel, and modify the risk assessment process as needed to be applicable to current and new processes.  It will be the responsibility of the individual to participate in the planning and execution of the final manufacturing processes under cGMP to ensure final processes reflect the set points, and address the risks, identified in the pre-manufacturing demonstration batches.  The individual will also be expected to setup and perform routine operation of small scale laboratory drug product manufacturing equipment for investigational use by the Pharmaceutics and Engineering departments.  This will also include independent design and execution of scale up and robustness evaluation of formulation processes.  The individual will be responsible for identifying common best practices for new and routine processes, revising of SOP’s as need, and authoring of SOP’s for new equipment and processes.  Finally, the individual will be responsible for identifying and researching background for equipment purchases and making recommendation to management. 

Responsibilities include the following. 

  • Responsible for oral dosage formulation development, process scale up and technology transfer from R&D to GMP manufacturing.
  • Responsible for technical oversight during Phase 1 & 2 GMP manufacturing operations.
  • Responsible for process technology training, equipment SOP writing and Validations.
  • Provide training and support to R&D personnel during the development and scale up of powder and liquid formulations.
  • Draft and execute production variance and Corrective Action Preventative Actions.
     

Qualifications

  • Bachelor's degree in Chemistry, Chemical Engineering, Pharmaceutical Sciences, or related field, with five to 10 years of practical pharmaceutical process support engineering experience.
  • 5+ years of experience of solid-oral formulation techniques as follows:Blending, milling, automated tablet compression, automated encapsulation, granulation, coating, spray drying
  • Current knowledge of GLP and GMP regulations, practices and documentation
  • Must possess in depth knowledge of principles, concepts and practices in pharmaceutical sciences and manufacturing processes, knowledge of small molecule process technologies for oral dosage forms preferred.
  • Well developed interpersonal, organization and communication skills, ability to work effectively with staff members at all levels, strong technical writing skills, and strong background in cGMP regulations.
  • Proficient in Microsoft Office (Excel and Word)
  • Ability to work independently on multiple concurrent projects with minimal guidance and to meet project deadlines.
  • Previous supervisory experience preferred.

About Catalent

Catalent Pharma Solutions is the leading global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products.  With over 80 years serving the industry, Catalent has proven expertise in bringing more customer products to market faster, enhancing product performance and ensuring reliable clinical and commercial product supply. For more information, visit www.catalent.com

More products. Better treatments. Reliably supplied.™

Catalent is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, or protected veteran status.

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 along with the job number and title to Jobs@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be routed to a 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

 

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