Subject Matter Expert Serialization

Contract Role 12-16 months.
Location: Hybrid (Puerto Rico/Ohio)
About the Role:
Our client is seeking a highly skilled and experienced SME (Subject Matter Expert) in Serialization, with a strong background in implementing the Antares Track and Trace system for packaging lines within the pharmaceutical industry. This role requires the expertise to design, implement, and maintain serialization solutions to meet regulatory compliance and enhance product traceability. The ideal candidate will be based in Puerto Rico and willing to relocate temporarily to Ohio, with all relocation costs covered by the company. This position offers a hybrid work arrangement to accommodate the project phases and collaboration with the team.
Key Responsibilities:

• Lead the design and implementation of the Antares Track and Trace serialization solution for pharmaceutical packaging lines.
• Ensure compliance with global serialization regulations and standards, including DSCSA, EU FMD, and others relevant to the pharmaceutical industry.
• Collaborate with cross-functional teams, including engineering, IT, and production, to integrate serialization systems seamlessly into existing processes.
• Provide expert advice and support on serialization best practices, system configurations, data management, and troubleshooting.
• Manage project timelines, documentation, and reporting related to serialization system implementations and upgrades.
• Conduct training sessions for internal teams on the operation and maintenance of the serialization systems.
• Liaise with external vendors, partners, and regulatory bodies as required.

Qualifications:

• Bachelor's degree or higher in Engineering, Computer Science, or a related Science field.
• Proven experience in implementing and managing Antares Track and Trace systems for the pharmaceutical industry.
• Deep understanding of pharmaceutical packaging processes and regulatory requirements related to product serialization and traceability.
• Strong analytical and problem-solving skills, with the ability to manage complex projects and multi-task effectively.
• Excellent communication and interpersonal skills, with the ability to work collaboratively in a team environment.
• Willingness to temporarily relocate to Ohio, with all relocation costs covered. Hybrid work arrangement available.
• Candidates must be from Puerto Rico, demonstrating a strong connection to the region and its talent pool.

Physical/Mental Requirements

• Able to stand for extended hours for test runs
• Able to climb ladders/steps
• Able to lift items of 25lbs.

What We Offer:

• Competitive compensation.
• Relocation support, including costs associated with temporary relocation to Ohio.
• Hybrid work arrangement to provide flexibility.
• Opportunity to work on cutting-edge serialization projects in the pharmaceutical industry.
• A dynamic and supportive work environment, with opportunities for professional growth and development.

How to Apply:
Please submit your resume, cover letter, and any relevant certifications or documentation demonstrating your experience with Antares Track and Trace systems and pharmaceutical serialization projects. Include references and a brief statement on your willingness to relocate temporarily to Ohio for this project.
Our client is an Equal Opportunity Employer and considers applicants for all positions without regard to race, color, religion, ancestry, national origin, age, gender identity, gender expression, sex/gender, marital status, sexual orientation, physical or mental disability, medical condition, military/veteran status, basis of genetic information, or any other group protected by law.