- Be involved in design of experiments, development of new methodologies and improving existing methodologies, data generation, report development and presentation.
- Schedule, plan, communicate, and manage documents and follow-up on validation activities. Interpret and apply regulatory requirements concerning validation activities.
- pplies knowledge or quickly learn cGXPs, relevant SOP curriculum, routine project procedures, project management, and other training as appropriate.
- Perform validation activities to lead and/or support cleaning, equipment, computer systems, utility, facility, and method validations.
- Review and generate quality documents including validation protocols, SOPs, change controls, and non-conformance event records as required.
- Serves as a project lead for projects of intermediate scope with cross-functional teams.
- ble to prioritize workload and tasks. Ability to follow good project management practices to meet schedules while ensuring compliance with procedures and regulations.
- Direct experience with writing and executing validation protocols is preferred.
- Understand scientific strategies and be able to invent new methods or new avenues of investigation.
- Good interpersonal/communication/influencing/negotiation skills.
- Strong project management skills
- bility to communicate effectively at all levels in verbal and written form, including technical/business writing.
- Proficient in Microsoft Word and Excel, computer software. Some experience with statistical software helpful.
- Direct or indirect industry knowledge.
- bility to work independently or in teams.
- Physical demands of the position may require the ability to lift materials up to 20 lbs., dexterity to gown, mobility to maneuver around equipment, and enter into confined spaces.
- BS Degree in Science, Engineering or Math with at least one or more years of experience.
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Validation Engineer - Round Lake, United States - Katalyst Healthcares and Life Sciences
