Validation Engineer I

Position Summary

The Validation Engineer I is responsible for generating and executing protocols, creating summary reports and executing validation activities in FDA regulated biopharmaceutical environments. The role coordinates all validation activities by constant communication with affected departments and personnel.

Essential Functions

• Support collaboration with cross-functional departments, clients, CMOs, and vendors to meet project and company expectations and objectives.
• Aid in performing validation activities for equipment, utility systems, facilities, processes, and automation systems in compliance with approved SOPs, cGMPs, and applicable regulatory requirements.
• Generate, support, and execute validation protocols (IQ/OQ/PQ/CV/PV) of all site equipment including laboratory equipment, production equipment, utilities (as applicable) and other related systems in an FDA regulated environment.
• Generate and keep current inventory of GMP systems and requalification/periodic reviews schedules.
• Perform risk assessments for GMP systems as required.
• Plan validation efforts according to risk.
• Troubleshoot discrepancies reported during validation/qualification and assist senior engineers with resolutions.
• Support the Validation team purchasing acquisitions and oversee the supplies and equipment inventory as needed.
• Adhere to Standard Operating Procedures (SOPs), process improvements, and standardization of templates.
• Perform ad-hoc and cross-functional duties and/or projects assigned to support business needs and provide developmental opportunities.

Basic Qualifications

• Bachelor’s degree in a science or related discipline is required.
• 1+ years of relevant validation or GMP-regulated industry experience is required.
• Experience with facility commissioning and validation of equipment and facilities is required.

Preferred Qualifications

• Good technical document writing and reviewing with teams.
• Good understanding and application of validation principles, concepts, practices, and industry standards.
• Working knowledge of validation principles including commissioning, IQ/OQ/PQs related to equipment and facilities.
• Working knowledge of related quality systems such as change control; CAPA (including deviations/OOSs); training and document control is required.
• Working knowledge of GMPs, OSHA compliance, 21 CFR Part 11 and cleanrooms, automated biopharmaceutical processing and plant equipment.
• Good interpersonal skills and the ability to work well independently and in a team environment.
• Good communication and organizational skills.