Manufacturing Sciences and Technology (MS&T) Engineer III
Position Summary:
- Work Schedule: Monday-Friday, 8:00am-4:30pm
- 100% on-site (San Diego)
Catalent, Inc. is a leading global Contract Development and Manufacturing Organization (CDMO), and Our purpose-built San Diego location provides comprehensive clinical supply services including clinical supply management, primary and secondary packaging, complex labeling services, clinical storage, distribution, and clinical returns and destruction, and will also include stability chambers. Located less than a mile from Catalent’s West Coast early-phase oral drug product development center of excellence, customers choosing this convenient Catalent location can now enjoy a fully integrated development, clinical supply manufacturing and distribution solution.
The Manufacturing Sciences and Technology (MS&T) team supports technical process development and transfer for San Diego Ware operations, partnering with clients to develop packaging and manufacturing solutions. In this role, you will help manage and execute assigned projects, support technology transfer for both internal and external processes, and maintain accurate technical documentation—including reports, batch records, packaging diagrams, and specifications. You will work cross‑functionally with Project Management, Manufacturing, Quality, Supply Chain, and Facilities to ensure processes are successfully transferred and maintained in compliance with cGMP and change control requirements. As the Catalent Operations Advocate, you will promote continuous improvement and uphold strong professionalism and Customer Service Excellence while communicating with internal and external stakeholders.
The Role:
- Lead MS&T team to coordinate projects ensuring correct technical requirements documentation generated, monitored and drive successful adherence and completion.
- Works cross functionally with project managers, production, label design and control, quality assurance, quality control, supply chain, and facilities departments to effectively transfer and maintain processes in the facility.
- Leads the compilation of process data, including communicating project status, and delivering internal and client presentations.
- Collects and trend process data for external (Clients) and internal review to ensure process consistency.
- Provides business case for process improvement projects.
- Authors and reviews technical reports, source documents, SupplyFlex records, legacy records, master batch records, product and equipment specifications, protocols and any other technical documents not listed in support of tech transfer and cGMP activities.
- Acts as the lead for technical support deviations, change controls, and CAPAs including determination of event impact, root-cause analysis, and corrective action identification.
- Responsible for maintaining a high performing team by hiring, training, motivating, evaluating, and developing staff.
- Drive departmental training.
- Author and regularly review Standing Operating Procedures relating to your own areas of responsibility.
- All other duties as assigned.
The Candidate:
- Bachelor’s degree in Engineering, or Science required; Packaging Engineering or Packaging Sciences preferred.
- Minimum of 5 years of experience with GMP equipment, manufacturing, healthcare, and/or pharmaceutical preferred
- Project management experience and skills preferred
- Minimum of 3 years of experience in a customer service or appropriate business-related area
- Experience writing SOPs, batch records, and technical reports; leading cross‑functional method development, qualification, and tech transfer activities; and executing investigations, deviations, and change controls with a right‑first‑time mindset required.
- Strong time‑management, organization, and communication skills with the ability to manage multiple priorities, deliver high‑quality customer service, and collaborate effectively across teams and with clients.
- Proficient in Microsoft Office (Word, PowerPoint, Excel, Visio) with ability to learn specialized systems (e.g., TOPS Pro, TrackWise®, ComplianceWire®); Artios CAD experience preferred.
- Demonstrated ability to analyze and interpret data, perform peer reviews, identify trends, troubleshoot issues, and drive corrective actions, risk assessments (FMEA, Hazard Analysis), and process improvements.
- Physical Requirements: able to perform duties which include standing, walking, sitting, kneeling, push/pulling frequently and significant amount of use of office equipment; Must be able to lift up to 35lbs and work in temperature-controlled freezers/fridges occasionally.
The anticipated salary range for this role in California is $110,000 - $125,000. The final salary offered to a successful candidate may vary, and will be dependent on several factors that may include but are not limited to: the type and length of experience within the job, type and length of experience within the in