We are seeking a CQV Specialist - Packaging Equipment who will support commissioning, qualification ... labelers, cartoners, serialization systems, inspection systems, and associated utilities.
We are seeking a CQV Specialist - Packaging Equipment who will support commissioning, qualification ... labelers, cartoners, serialization systems, inspection systems, and associated utilities.
We are seeking a CQV Specialist - Packaging Equipment whowill support commissioning, qualification ... labelers, cartoners, serialization systems, inspection systems, and associated utilities.
We are seeking a CQV Specialist - Packaging Equipment whowill support commissioning, qualification ... labelers, cartoners, serialization systems, inspection systems, and associated utilities.
Serialization Specialist information
What are the key skills and qualifications needed to thrive as a serialization specialist?
To thrive as a Serialization Specialist, you need in-depth knowledge of pharmaceutical supply chain processes, regulatory compliance (such as DSCSA and EU FMD), and a relevant technical or scientific degree. Familiarity with serialization software (e.g., SAP ATTP, TraceLink), barcode systems, and data management tools is typically required. Strong analytical thinking, attention to detail, and effective communication skills help ensure accuracy and collaboration across departments. These skills are crucial for maintaining regulatory compliance, ensuring product traceability, and safeguarding patient safety in pharmaceutical distribution.
What is a serialization specialist?
Serialization Specialists are professionals responsible for ensuring that products, especially in the pharmaceutical and food industries, are properly serialized and tracked through the supply chain. They implement and manage systems that assign unique identifiers to products, which helps prevent counterfeiting, ensures regulatory compliance, and improves traceability. Their work often involves working with specialized software, coordinating with production teams, and maintaining compliance with government regulations related to serialization. Serialization Specialists play a key role in product safety and supply chain integrity.
What are some common challenges faced by serialization specialists when implementing serialization systems in pharmaceutical manufacturing?
Serialization Specialists often encounter challenges such as integrating new serialization software with existing manufacturing execution systems, ensuring data accuracy across multiple packaging lines, and maintaining compliance with evolving global regulations. They must also coordinate closely with quality assurance, IT, and supply chain teams to troubleshoot issues and implement process improvements. Staying updated on regulatory requirements and adapting serialization solutions to meet diverse market needs are key aspects of the role.
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The top searched job categories for Serialization Specialist jobs in Ohio are:
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Job description
Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.
We are seeking a CQV Specialist - Packaging Equipment who will support commissioning, qualification, and validation activities for packaging equipment and systems in a biotechnology manufacturing environment. The role ensures that packaging lines are installed, tested, and documented in compliance with GMP, FDA, and internal quality requirements while supporting project schedules and startup activities. This is an onsite opportunity in New Albany, OH.
Key Responsibilities
- Support commissioning, qualification, and validation (CQV) activities for primary and secondary packaging equipment and systems.
- Develop, review, and execute commissioning and qualification documentation including protocols such as IQ, OQ, and PQ.
- Verify installation and operational readiness of packaging equipment including labelers, cartoners, serialization systems, inspection systems, and associated utilities.
- Coordinate activities with engineering, quality assurance, validation, manufacturing, and vendors to ensure proper startup and qualification of packaging lines.
- Support protocol deviations, discrepancy resolution, and documentation updates as required.
- Assist with risk assessments, test planning, and validation strategies in accordance with project and regulatory requirements.
- Ensure compliance with cGMP, FDA regulations, and company validation procedures.
- Support FAT/SAT activities, startup, and troubleshooting during commissioning phases.
- Maintain accurate documentation and support turnover packages for validated systems.
Qualifications
- Bachelors degree in Engineering, Life Sciences, or related technical discipline.
- 5+ years of experience in CQV, validation, or commissioning within pharmaceutical or biotechnology manufacturing environments.
- 2+ years of experience qualifying packaging line equipment such as fillers, labelers, cartoners, serialization/aggregation systems, vision inspection systems, and case packers.
- Strong knowledge of cGMP regulations, FDA requirements, and validation lifecycle practices.
- Experience writing and executing validation documentation (IQ/OQ/PQ, protocols, reports, discrepancies).
- Ability to work cross-functionally with engineering, quality, operations, and project management teams.
- Strong technical writing and documentation skills.
- Experience supporting equipment startup, FAT/SAT, and commissioning activities in a regulated environment.
- Available to work extended hours, possibility of weekends and holidays.
At Validation & Engineering Group, people always come first. We believe that when you're empowered to do your best work, bold ideas thrive and real progress happens. This isn't just a job - it's an opportunity to make a meaningful difference by shaping the future of healthcare and technology alongside a purpose-driven, supportive team.
Excited to build something meaningful together? We look forward to hearing from you.
Validation & Engineering Group is an equal opportunity employer. All applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability status.
About Pinnaql
Sourced by ZipRecruiter
Industry
Pharmaceutical and medicine manufacturing
Company size
11 - 50 Employees
Headquarters location
Malvern, PA, US
Year founded
2019