Catalent Pharma Solutions Project Manager-Product Serialization in Somerset, New Jersey
Job Title: Project Manager-Product Serialization
City: SomersetState: New Jersey
Run global programs with large teams and manage budgets across multiple countries (large multi-year, multi-million dollar implementations).
Act as subject matter professional on Serialization for compliance with global regulatory requirements including USA FDA Law (DSCSA – Drug Supply Chain and Security Act), South Korea, China, Brazil, EU (FMD – Falsified Medicines Directive) and other markets serialization requirements.
Configure IT and Packaging line serialization systems to support global Serialization regulatory requirements
Manage and support delivery of supply chain, e-pedigree, and unique device identification and serialized product tracking services to Life Sciences customers.
Gather functional/business requirements for solution design for packaging and warehouse operations
Determine appropriate revenue recognition; ensure timely and accurate invoicing; and monitor receivables for project.
Validate and qualify IT systems used in pharmaceutical environments. Develop full validation documentation and testing protocols (IQ/OQ/PQ/UAT) within various SDLC phases and resolve issues throughout the project life cycle.
Assist existing teams in software qualification and software validation activities and further provide assistance to Serialization support team to manage serialized lines.
Provide engineering support in 24/7 environment to Automation and IT systems
Interact with internal and external business user in requirement gathering and analysis, work with enterprise architects and middleware team for data requirements
Develop engineering documents including: detailed design specifications; interface guides; drawings; installation and operation qualification protocols; for validation
Design and Deploy automation solutions including Instrumentation; Control systems; PLCs; machine vision systems
Formal investigation of support issues, communication with impacted stakeholders, vendor, resolution/closure of the issue, and update appropriate knowledge management records.
Conduct system user training for operators and supervisors and support Go-live activities
Represent company at public conferences for Serialization capabilities
Lead and support business development activities including identification, proposal development, and other pursuit activities
Participate in Continuous Improvement initiatives after deployment of projects
Participate in internal and external audits related to Serialization
Perform all of the foregoing work in IT, QA, manufacturing, distribution, Regulatory, and/or product labeling in the pharmaceutical, medical device or life science industry.
20.Travel required 25% of the time.
EDUCATION AND EXPERIENCE REQUIREMENT: Bachelor’s degree in Business, Instrumentation, Computer Science, Electrical Engineering or a related field and 5 years of experience in the job offered or 5 years of experience in the Related Occupation OR a Master’s degree in Business, Instrumentation, Computer Science, Electrical Engineering or a related field and 3 years of experience in the job offered or 3 years of experience in the Related Occupation
Project Manager or any other job title performing all listed job duties.
JOB TIME: Full Time
Catalent offers rewarding opportunities to further your career – join the global drug development and delivery leader! You will help develop some of the nearly 200 products we launch each year or help supply some of the over 7,000 products for patients around the world. Our highly skilled, dedicated global team of over 9,500 is passionate about improving the health of patients by combining their personal expertise with advanced technologies to advance science and supply innovative new products of the highest quality to patients globally.
Gain unparalleled experience by working on multiple products and technologies – we launch nearly 200 new products for our customers each year.
We have 20 global pharmaceutical Product Development teams on five continents, who are, at any given time, working on over 700 new products and hundreds of ongoing clinical trials.
Our products include some of the latest life-saving medicines as well as some of the most well-known consumer health brands used by families every day.
Catalent’s more than 30 global facilities on 5 continents manufacture over 70 billion doses of over 7,000 important medicines and consumer health products.
Nearly 1 in 20 doses of medicines taken around the world has been touched by the Catalent team.
We have +1,100 patents on many superior patient-preferred technologies used by all the top pharmaceutical, biologic and consumer health companies.
We established the Catalent Applied Drug Delivery Institute to drive collaboration and scientific exchange among industry professionals, academics and partners.
Many of our 1,400+ scientists are regularly published in top industry journals and present at top industry conferences to advance knowledge sharing and the development of better life-saving medicines.
Catalent is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, or protected veteran status. 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 along with the job number and title to Jobs@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be routed to a recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.