Senior Packaging Specialist
Catalent, San Diego, CA, United States
Senior Packaging 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 Sr. Packaging Specialist for our Clinical Supply Services group will work in a team environment to offer quality packaging and labeling of customers' clinical trials. This person will lead production rooms and ensure quality product output from production batch records. Additionally, this role will have responsibilities for label control and training of new staff. Employees will be involved with handling look-alike products and labeling. Clinical operations can be run as a blister fill, bottle fill, pouch, carding, vial/syringe inspection or hand assembly. Employees will also be involved with de-inking of products and capsule manufacturing. The Role: Lead production room activities from pre-line setup through execution and post-line closeout, ensuring smooth daily operations. Maintain and manage the production schedule in partnership with the Production Manager, including staff coordination and room oversight Serve as JDE subject matter expert (SME) for production-related system transactions and workflows. Conduct on-the-job training (OJT) for production team members and ensure adherence to SOPs and operational standards Perform EBR reviews, support deviation or complaint investigations, and ensure accurate completion of required logbooks and documentation Manage label control processes, including label printing, creation of master blinding forms, and initial/final label inspections with 100% accountability for clinical labels. Inspect sealed clinical cards, labels, and associated packaging components for print accuracy, seal integrity, and overall quality Perform inspections for blisters, bottles, pouches, vials, ampoules, syringes, and multi-fill card placement using visual checks and light boxes as required. Execute assembly operations utilizing barcode scanners and computer systems, including Fastchain production tasks with a 3-day turnaround requirement Fill hoppers with tablets, bottles, desiccants, and closures; conduct hand-counting activities and perform specialized manufacturing tasks such as de-inking, tablet breaking, and capsule oversizing Clean production rooms, equipment, and product-contact parts per SOPs, including three bucket mop procedures, while maintaining strict segregation protocols for lookalike and multi fill products Other duties as assigned The Candidate: High School Diploma/GED or equivalent required. Bachelor's degree preferred Minimum of six (6) years of relevant industry experience in a cGMP environment, or comparable pharmaceutical or clinical knowledge and experience Minimum of four (4) years of operating and maintaining packaging equipment (blistering, bottling, carding) or relevant packaging equipment experience Basic knowledge is required in Microsoft Office software and query-based systems activities as well as electronic batch record (EBR) software Must be able to follow written and oral instructions in an accurate manner and problem-solve using analytical skills Must be able to work overtime as required 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 frequently Pay: The anticipated salary range for this role in San Diego, CA is $55,000 to $65,000 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, 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.
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 Sr. Packaging Specialist for our Clinical Supply Services group will work in a team environment to offer quality packaging and labeling of customers' clinical trials. This person will lead production rooms and ensure quality product output from production batch records. Additionally, this role will have responsibilities for label control and training of new staff. Employees will be involved with handling look-alike products and labeling. Clinical operations can be run as a blister fill, bottle fill, pouch, carding, vial/syringe inspection or hand assembly. Employees will also be involved with de-inking of products and capsule manufacturing. The Role: Lead production room activities from pre-line setup through execution and post-line closeout, ensuring smooth daily operations. Maintain and manage the production schedule in partnership with the Production Manager, including staff coordination and room oversight Serve as JDE subject matter expert (SME) for production-related system transactions and workflows. Conduct on-the-job training (OJT) for production team members and ensure adherence to SOPs and operational standards Perform EBR reviews, support deviation or complaint investigations, and ensure accurate completion of required logbooks and documentation Manage label control processes, including label printing, creation of master blinding forms, and initial/final label inspections with 100% accountability for clinical labels. Inspect sealed clinical cards, labels, and associated packaging components for print accuracy, seal integrity, and overall quality Perform inspections for blisters, bottles, pouches, vials, ampoules, syringes, and multi-fill card placement using visual checks and light boxes as required. Execute assembly operations utilizing barcode scanners and computer systems, including Fastchain production tasks with a 3-day turnaround requirement Fill hoppers with tablets, bottles, desiccants, and closures; conduct hand-counting activities and perform specialized manufacturing tasks such as de-inking, tablet breaking, and capsule oversizing Clean production rooms, equipment, and product-contact parts per SOPs, including three bucket mop procedures, while maintaining strict segregation protocols for lookalike and multi fill products Other duties as assigned The Candidate: High School Diploma/GED or equivalent required. Bachelor's degree preferred Minimum of six (6) years of relevant industry experience in a cGMP environment, or comparable pharmaceutical or clinical knowledge and experience Minimum of four (4) years of operating and maintaining packaging equipment (blistering, bottling, carding) or relevant packaging equipment experience Basic knowledge is required in Microsoft Office software and query-based systems activities as well as electronic batch record (EBR) software Must be able to follow written and oral instructions in an accurate manner and problem-solve using analytical skills Must be able to work overtime as required 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 frequently Pay: The anticipated salary range for this role in San Diego, CA is $55,000 to $65,000 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, 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.