Manufacturing Sciences and Technology (MS&T) Engineer III
100% on-site (San Diego) – Monday-Friday, 8:00am-4:30pm
About the Role
Catalent’s purpose-built San Diego location provides comprehensive clinical supply services including clinical supply management, primary and secondary packaging, complex labeling services, clinical storage, distribution, clinical returns and destruction, and stability chambers. Located less than a mile from Catalent’s West Coast early-phase oral drug product development center of excellence, customers can 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.
Responsibilities
- Lead MS&T team to coordinate projects ensuring correct technical requirements documentation is generated, monitored, and drive successful adherence and completion.
- Work 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.
- Lead the compilation of process data, including communicating project status and delivering internal and client presentations.
- Collect and trend process data for external (clients) and internal review to ensure process consistency.
- Provide business cases for process improvement projects.
- Author and review technical reports, source documents, SupplyFlex records, legacy records, master batch records, product and equipment specifications, protocols, and any other technical documents in support of tech transfer and cGMP activities.
- Act as the lead for technical support deviations, change controls, and CAPAs including determination of event impact, root-cause analysis, and corrective action identification.
- Maintain 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.
- Perform all other duties as assigned.
Requirements
- 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 the 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, pushing/pulling frequently, and significant use of office equipment.
- Must be able to lift up to 35 lbs and work in temperature-controlled freezers/fridges occasionally.
Pay
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 including but not limited to: type and length of experience within the job, type and length of experience within the industry, skillset, education, and business needs.
Benefits
- Competitive salary with bonus potential.
- Generous 401K match and Paid Time Off accrual (152 hours of PTO + 10 paid holidays).
- Medical, dental, and vision benefits effective day one of employment.
- Tuition Reimbursement.
- WellHub program to promote overall physical wellness.
- Perkspot – offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories.
- Awesome employee activities: Movie Day, Monthly Birthday Celebrations, Friday Bagel Breakfast, On-site Fitness Center with machines, on-site yoga classes, Sponsored Sports Teams, and several other company-sponsored events.
- Environmentally friendly green initiatives with on-site practices as well as regular participation 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.