Process Excellence Specialist

Catalent•San Diego, CA

11d•$80,000 - $90,000•Onsite

About The Position

Process Excellence Specialist Position Summary: Work Schedule: Monday-Friday, core hours 8am-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 Process Excellence & Change Management Champion will play a pivotal role in driving process improvements and managing change within the site and the Clinical and Specialty Services segment. This position is responsible for supporting the implementation of new systems, Standard Operating Procedures (SOPs), and Work Instructions (WIs), ensuring GMP compliance, and fostering a culture of continuous improvement. The individual will work closely with the Process Excellence central team to drive system and process adoption using key change management strategies.

Requirements

Bachelor of Science in Engineering, Pharmaceutical Sciences, or a related field is required.
Minimum of two (2) years of experience with pharmaceutical packaging and distribution processes, Standard Operating Procedures (SOPs) and GxPs
Minimum of one (1) year of experience with technical writing such as validation reports, engineering documents, controlled documents (SOPs, Batch Records, Work Instructions) in a GxP environment
Thorough knowledge of systems – JD Edwards 9.2, DSI, GSA, SupplyFlex, ComplianceWire, TrackWise, EDMS, etc.
Work independently or as part of a team, adopting a right-first-time approach ensuring the commitments are met in a timely manner.
Demonstrated professionalism including excellent work ethic, positive attitude and experience communicating with external clients.
Ability to follow and provide a variety of instructions furnished in written, oral, diagram, or schedule form.
Must be able to communicate effectively with internal and external customers, peers and managers
Physical requirements: able to perform duties which include standing, walking, sitting frequently and significant amount of use of office equipment and computers, keyboards, and writing by hand; Must be able to lift up to 35lbs and work in temperature-controlled freezers/fridges occasionally

Nice To Haves

Lean Six Sigma Green Belt certification is highly desirable

Responsibilities

Lead change management initiatives for new systems, SOPs, and Work Instructions.
Collaborate cross-functionally and with the Process Excellence central team to drive system and process adoption
Develop, author and update SOPs and work instructions to align with best practices.
Supports training and optimization of those procedures
Assist in User Acceptance Testing (UAT) to ensure successful system implementation
Promote and lead operational excellence and continuous improvement initiatives within the site to enhance operational efficiency.
Ensure all processes comply with GMP standards
Continuously seek opportunities for process optimization, cost reduction, and innovation through the application of new technologies, best practices, and lessons learned from operational experience
Facilitate cross-functional problem-solving events.
Participate in and facilitate Rapid Response Team fact gathering
Deploy industry-standard lean and six sigma tools to address the root causes of non-conforming quality events
Other duties as assigned

Benefits

Awesome employee activities: Movie Day, Monthly Birthday Celebrations, Friday Bagel Breakfast, On-site Fitness Center with machines, on-site yoga and HIIT classes, 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.