The Role (daily responsibilities)
- Management of the preventative maintenance (PM) program.
- Take initiative/proactive approach in identifying and executing manufacturing process, procedural or cost improvements.
- Manage multiple complex projects simultaneously, from researched design through proposal, execution and high quality results.
- Stay abreast of new technologies appropriate to Catalent San Diego and present recommendations to Senior Management
- Manage budget, coordinate approval, purchasing and delivery.
- Bring equipment online – cGMP documentation, installation, training.
- Write and review GMP documents such as SOP’s, equipment validations, and technical reports.
- Conduct root cause analysis and lead OOS investigations.
- Provide technical support and engineering oversight to GMP operations.
- Demonstrate ability to work across multiple engineering disciplines.
- Manage and mentor staff of direct reports as well as junior level technical personnel.
- Represent Catalent San Diego Engineering in scientific discussions/client project planning meetings.
The Candidate (requirements)
- Bachelors degree in Engineering, from an accredited university, and a minimum of 5 years of applicable cGMP industry engineering experience is required. 3+ years of management/leadershipexperience is desired.
- Strong written and oral communication skills including the ability to speak effectively before groups of customers or employees of the organization and the ability to read, write, and comprehend routine reports and correspondence.
- Excellent accountability, high attention to detail, and strong organizational skills
- Ability to apply scientific knowledge and understanding of the industry regulations to applicable internal issues.
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.