Engineering Associate Validation

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

III. Position Requirements

Education and Experience:

Bachelors Degree in Life Sciences, Physical Science, Computer Science or Engineering field with minimum of 3 years relevant experience, OR

Masters 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.

Knowledge/Skills Requirements:

Proficient in Microsoft Office products (Word, Excel, etc.)

Basic understanding on Minitab or equivalent statistical tool.

Experience with IQ, OQ, and PQ activities

Experience with GMP and GDP activities.

Project management skills

EEO:- Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans