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.
The Role:
- 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
The Candidate:
- Bachelor of Science in Engineering, Pharmaceutical Sciences, or a related field is required. Lean Six Sigma Green Belt certification is highly desirable
- 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
Pay:
- The anticipated salary range for this role in San Diego, CA is $80,000 to $90,000 annually. 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 industry, skillset, education, business needs, etc. Catalent is a multi-state employer, and this salary range may not reflect positions that work in other states.
Why you should join Catalent:
- 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.
Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.
personal initiative. dynamic pace. meaningful work.
Visit Catalent Careers to explore career opportunities.
Catalent is an Equal Opportunity Employer, including disability and veterans.
If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.
Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.
Important Security Notice to U.S. Job Seekers:
Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond— it is a fraudulent request. Please forward such requests to spam@catalent.com for us to investigate with local authorities.
California Job Seekers can find our California Job Applicant Notice HERE.