Packaging Validation Expert

1 week ago


Jersey City, New Jersey, United States Spark Life Solutions, Inc. Full time
About the Role

At Spark Life Solutions, Inc., we are seeking a highly skilled Validation Engineer to join our team. As a key member of our quality assurance department, you will be responsible for ensuring that our products meet the highest standards of quality and safety.

The ideal candidate will have a strong background in validating packaging lines, labelers, case packers, and low-speed pen assembly systems, as well as experience working in aseptic environments within the biotechnology or pharmaceutical industries. We are looking for someone who is knowledgeable about SEA Vision Yudoo and AVI systems and has a proven track record of meeting deadlines and delivering high-quality results.

Responsibilities:
- Develop and execute comprehensive validation plans for packaging lines, labelers, case packers, and low-speed pen assembly systems
- Validate SEA Vision Yudoo and AVI systems to ensure strict compliance with industry standards and regulatory requirements
- Collaborate with cross-functional teams to facilitate seamless execution of validation activities and address any technical or operational challenges

Requirements:
- Bachelor's degree in Engineering, Life Sciences, or a related field (or equivalent professional experience)
- Proven expertise in aseptic environments within the biotechnology or pharmaceutical industries
- Minimum of 10 years' experience validating packaging lines, labelers, case packers, and low-speed pen assembly systems
- Demonstrated knowledge of SEA Vision Yudoo and AVI systems validation
- Proficiency in developing validation plans and executing IQ, OQ, PQ, and VSR documentation
- Familiarity with FDA, ISO, and GMP regulatory guidelines
- Strong analytical, troubleshooting, and problem-solving abilities
- Excellent verbal and written communication skills
- Ability to work independently and collaboratively in a dynamic team environment


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