Validation Associate
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EEO Employer
LanceSoft is a certified Minority Business Enterprise (MBE) and an equal opportunity employer. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws.
This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, training, and apprenticeship. LanceSoft makes hiring decisions based solely on qualifications, merit, and business needs at the time.
This position serves as a validation representative for laboratory validation activities, including Equipment Qualification and system administration. In addition, this position is expected to provide technical guidance as A SME with respect to validation/process deviations and change controls as pertains to validation impact.
II. Essential Functions
- Generate, execute and summarize validation documentation for process equipment qualification.
- Lead Validation/Qualification/CSV efforts for equipment purchased or modified (FAT, SAT, OQ, PQ).
- Coordinate with Quality, technical scientists, and vendors for validation protocols, execution, and final reports
- Generate, execute and summarize project plans, conduct and peer review change controls, review validation related exceptions events, as well as provide input to site as a SME.
- Contribute to the development and revision of validation concepts, techniques, and standards to ensure compliance with regulatory requirements.
- Assist in validation related issue resolutions for all GMP laboratory equipment.
- Generate and participate in any change control activities as required.
- Participate in any tasks associated with system implementation or upgrades as required.
- Lead/support periodic and data integrity reviews.
- Participate, support, and drive Continuous Improvement initiatives.
All other duties as assigned
Education and Experience:
- Bachelor s Degree in Life Sciences, Physical Science, Computer Science or Engineering field with minimum of 3 years relevant experience, OR
- Master s degree in related Life Sciences, Physical Science, Computer Science or Engineering field required with a minimum of 1 years relevant experience, OR
- Doctorate degree in related Life Sciences, Physical Science, Computer Science or Engineering field required with a minimum of 1 years relevant experience.
EEO Employer
LanceSoft is a certified Minority Business Enterprise (MBE) and an equal opportunity employer. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws.
This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, training, and apprenticeship. LanceSoft makes hiring decisions based solely on qualifications, merit, and business needs at the time.
