Principal Serialization Engineer

Job SummaryThe Serialization Principal Engineer is responsible for support of level 2-3 systems, SQL databases and the interface to FK SAP ERP/OER systems, who provides the IT support for all plants of GO NAM. The position is responsible for continuously monitoring the technical status and progress of the plan and support in FAT, SAT, IOQ and PQ testing, and ongoing improvements to existing level 2-3 systems in support of changing serialization requirements. Schedules, leads and follows up on packaging and serialization projects.
Salary Range: $90,816-$145,000 annually
Position is eligible to participate in a bonus plan with a target of 10% of the base salary
Final pay determinations will depend on various factors, including, but not limited to experience level, education, knowledge, skills, and abilities.
Our benefits and programs are comprehensive and thoughtfully crafted to ensure our colleagues live healthy lives and have support when it matters most. Benefits offered include a 401(k) plan with company contributions, paid vacation, holiday and personal days, employee assistance program, and health benefits to include medical, prescription drug, dental and vision coverage.

Responsibilities

• Supports Director, Serialization & Packaging Engineering on ongoing GO NAM serialization and packaging projects from planning, scheduling, allocation of resources, execution and closure.

   Supports MS SQL server databases in GO NAM by troubleshooting and fixing any issues related to the database functionality, restore backup data, and guarantee 24/7 service availability.

• Supports PCE level 2-3 system by troubleshooting and fixing any issues related to the PSM (Pilot Site Manager), PLM (Pilot line manager) and GlassFish 4 application server, guarantee 24/7 service availability. Perform necessary patch installation based on xGMP and critical computer system validation requirements.

   Supports SAP OER SNMS (Serial number serialization system).

• Creating serial number list for specific product GTINs. Creating different serialization templates for encodings, maintenance of Material master data, product information.

• Evaluates and technical assesses with proposed serialization and packaging solutions. Reviewing of different solution existing on the market

• Sets up Material master data systems in TraceLink, SAP and serializations systems

• Communicates and coordinates projects with external entities and global partners like CMO, TPM and FK suppliers.

•  SME for packaging and serialization system. Provided support at the plant level to the packaging departments in Grand Island, Melrose Park, and Wilson facility’s

• Responsible for creation, approval, and execution of projects documentation like URS, FAT, SAT, DIRA, MIRA, FS, etc.

Requirements

•  Bachelor’s degree in computer science or related field
• At least 5 years of experience in serialization and packaging projects in pharmaceutical industry or related
• SQL programming language/database administration knowledge
• Proficiency with SAP OER is preferred
• Proficiency with SAP ERP/R3 is preferred
• Proficiency with TraceLink Cloud Solution
• Knowledge of GS1 standards (EPCIS, etc.)
• Preferred exposure to different L2/L3/L4 solutions (Optel, Antares, NKPharma, Utophia, Shubham, rfXcel, TraceLink, Arvato, SAP Pharma Network, etc.)
• Excellent communication and conflict management skills
• Deep Knowledge of PCE or Wipotec serialization systems
• Knowledge of packaging equipment like vials/syringe labelers, tray packer, cartoners, case packer and palletizers, etc.
• The Company’s primary business language is English. The successful candidate must be able to effectively speak, read, write, and understand English to perform the essential functions of the position, including independently understanding policies, procedures, training materials, and workplace communications written in English due to our heavily regulated work environment.

Additional Information

We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company contribution, and wellness program.

Please note that joining our team does not create a guaranteed or permanent employment arrangement. All employment is at‑will, meaning both the employee and Fresenius Kabi have the right to end the employment relationship at any time, in accordance with applicable federal and state laws.

Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.