Engineering - Associate, Validation

Payrate

$26.00 - $26.00/hr.

This position serves as a validation representative for laboratory validation activities, including equipment qualification and system administration. In addition, the role provides technical guidance as an SME with respect to validation/process deviations and change controls pertaining to validation impact.

• Generate, execute, and summarize validation documentation for process equipment qualification.
• Lead validation/qualification and 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 and events; and provide input to the site as a SME.
• Contribute to the development and revision of validation concepts, techniques, and standards to ensure compliance with regulatory requirements.
• Assist in resolving validation‑related issues for all GMP laboratory equipment.
• Generate and participate in any change control activities as required.
• Participate in tasks associated with system implementation or upgrades as required.
• Lead and support periodic and data integrity reviews.
• Participate, support, and drive continuous improvement initiatives.
• Perform all other duties as assigned.

• Bachelor’s, Master’s, or Doctorate in Life Sciences, Physical Sciences, Computer Science, or Engineering with 3+ years (Bachelor’s) or 1+ year (Master’s/Doctorate) of relevant experience.

• Proficient in Microsoft Office products (Word, Excel, etc.).
• Basic understanding of Minitab or equivalent statistical tool.
• Experience with IQ, OQ, and PQ activities.
• Experience with GMP and GDP activities.
• Project management skills.

The typical base pay for this role across the U.S. is $26.00 - $26.00/hr. Non‑exempt positions are eligible for overtime at a rate of 1.5 times the base hourly rate for all hours worked in excess of 40 in a work week, or as required by state or local law. Full‑time employees are eligible to select from different benefits packages, which may include medical, dental, and vision benefits, health savings accounts, 10 paid days off, 3 days paid bereavement leave, 401(k) plan participation with employer match, life and disability insurance, commuter benefits, dependent care flexible spending account, accident insurance, critical illness insurance, hospital indemnity insurance, accommodations and reimbursement for work travel, and discretionary performance or recognition bonus.

Sick leave and mobile phone reimbursement provided based on state or local law.