Job Title

Serialization Support Analyst

Relevant Experience

(in Yrs)

2-5 Years

Must Have Technical/Functional Skills

• Experience of Process Automation Systems
• Experience in Systech suite of products (Systech Guardian, Advisor and Sentri) Track & Trace, Serialization & Brand Protection - Systech
• Experience working with Systech product team and process automation and engineering teams.
• Experience and in-depth understanding of all system lifecycle deliverables from Commissioning & Qualification (C&Q) and Computer System Validation (CSV) documents through System Retirement. This includes deliverables such as Planning (Project Validation Plan or Validation Master Plan), User/Functional Requirements, Design Specifications, Design Qualification (DQ), Commissioning (FAT, SAT, Startup), Qualification Test Protocols (IQ/OQ/PQ), Process Validation (PV).
• Experience in pharma packaging processes and packaging equipment custom software
• Strong problem-solving and strong analytical skills are essential. Ability to troubleshoot issues and provide timely resolution.
• Excellent analytical, organizational, team, and project management and documentation skills
• Excellent written verbal communication skills
• Strong understanding of software development lifecycle and maintenance plans
• Experience working in a support role in a flexible schedule
• Experience in providing tier2 support in 24/7 pharmaceutical manufacturing and packaging operations
• Worked in direct support of and along with the maintenance staff to maintain both complex and straightforward systems used in packaging operations
• Experience with Systems Management (disaster recovery, problem management, incident management, change management etc).

Experience Required

• Experience in Pharma Serialization.
• Experience in Packaging line hardware and PLC programming.
• Experience in vision inspection systems used in packaging.
• Experience in formal Change Management and Incident Management Processes.
• Experience in Familiarity with Packaging solutions like Systech, RFexcel, etc.

Roles & Responsibilities

• Provide tier2 support to the Serialization Execution System.
• Assist existing teams in software qualification and validation activities and further assist the Serialization support team in managing serialized lines.
• Develop a global, repeatable, and logical process to effectively resolve any issues arising from the installation and subsequent operation of Serialization hardware components in packaging operations.
• Providing updates to customers regarding ongoing issues.
• Maintain and update procedures as required.
• Updating engineering, user requirements, and design documents for any changes made to the serialization system.
• Formal investigation of support issues, communication with impacted stakeholders and vendors, resolution/closure of the problem, and updating appropriate knowledge management records.

Generic Managerial Skills

• Resource should be quick learner and self-driven; capable of meeting with Business Users and working cross-functionally to define requirements, configure and deploy solutions
• Ability to plan and prioritize work effectively to meet defined delivery levels in a customer-facing role.
• Actively participate among cross-functional teams and lead project initiatives to ensure projects are delivered on time and to required quality standards

Education

Bachelor's Degree (4 yrs) in Industrial Engineering, /Automation Engineering/Mechanical Engineering.