Process Engineer III

Catalent•San Diego, CA

1d•$105,000 - $115,000•Onsite

About The Position

Position Summary: Work Schedule: Monday-Friday from 7:30am-4pm 100% on-site (San Diego) Catalent, Inc. is a leading global Contract Development and Manufacturing Organization (CDMO), and Catalent’s San Diego facility focuses on early-stage development of small molecule and peptide drug candidates from the bench to the clinic. This facility offers an array of services that support oral and injectable dosage forms that include preformulation testing, formulation and analytical development, cGMP manufacturing and clinical packaging, labeling, and worldwide distribution. Our San Diego location is the home of our Catalent Spray Drying technologies with downstream roller compaction capabilities to support the needs of our client’s most challenging compounds. The Process Engineer III will be responsible for conducting Good Manufacturing Practices (cGMP) manufacturing of solid oral and liquid oral pharmaceutical dosage forms for Phase I and Phase II clinical trials. Daily responsibilities will include execution and operation of small scale and pilot scale pharmaceutical manufacturing equipment without supervision for the purpose of evaluation of formulation and process procedures to determine their effects in relation to final product specifications. You will be a key member of a multi-site mission to deliver unparalleled service to our clients and quality drug products to the patients.

Requirements

Bachelor's degree is required in Chemistry, Chemical Engineering, Pharmaceutical Sciences (or related field) with a minimum of five (5) years of practical pharmaceutical process support engineering experience
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
Physical Requirements: On an average 8-hour day this position requires the ability to walk, sit, stand, and lift up to 25 pounds. Specific vision requirements including reading of written documents, visual inspection of materials and use of computer monitor screen frequently

Responsibilities

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 Standard Operating Procedure (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 (CAPA)
Other duties as assigned

Benefits

Awesome employee activities: Movie Day, Monthly Birthday Celebrations, Friday Bagel Breakfast, On-site Fitness Center with machines, Sponsored Sports Teams, and several other company-sponsored events that encourages positive employee comradery, which contributes to effectively building positive employee relationships, overall creating a positive work environment.
Environmentally friendly green initiatives with on-site practices as well as regularly participating in Beach Clean-up activities for community engagement.
Defined career path and annual performance review and feedback process. Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives.
Several Employee Resource Groups focusing on Diversity and Inclusion.
Competitive salary with bonus potential. Generous 401K match and Paid Time Off accrual. Medical, dental and vision benefits effective day one of employment.
152 hours of PTO + 10 paid holidays.
Positive and fast-paced working environment focusing on continually improving processes to remain innovative and dynamic.
Tuition Reimbursement – Let us help you finish your degree or earn a new one!
WellHub program to promote overall physical wellness.
Perkspot - offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories.