Validation Engineer II

Position Summary

The Validation Engineer II is responsible for generating and executing protocols, creating summary reports and executing validation activities in FDA regulated biopharmaceutical environments. Coordinates all validation activities by constant communication with affected departments and personnel. Will report to a manager or head of the department. The Validation Engineer II works on many phases/sub-tasks of projects of moderate complexity and working under general supervision or mostly independently with minimal supervision.

Essential Functions

• Collaborate with cross-functional departments to meet company expectations,
• Perform 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,
• Author and review SOPs, protocols, reports, and validation master plans for GMP equipment, instruments, and computerized systems,
• Generate and keep current inventory of GMP systems and requalification/periodic review schedules,
• Perform and lead risk assessments for GMP systems as required,
• Plan validation efforts according to risk,
• Collaborate with clients, CMOs, and vendors to meet project and company objectives,
• Assist with vendor communications,
• Troubleshoots and resolve discrepancy reported during validation/qualification.
• Performs ad-hoc and cross-functional duties and/or projects assigned to support business needs and provide developmental opportunities.

Basic Qualifications

• Bachelor’s degree in science or related discipline is required.
• 3+ 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

• Strong technical document writing and reviewing with teams
• Strong 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
• Strong interpersonal skills and the ability to work well independently and in a team environment
• Strong communication and organizational skills

Working Environment / Physical Environment

• This position works on-site.
• Exposure to onsite in-lab environment
• Must be able to don and wear Personal Protective Equipment (PPE) as required
• Lifting, standing, climbing, bending, grasping, sitting, pulling, pushing, stooping, stretching, and carrying are generally required to perform the functions of this position
• Must possess mobility to work in a standard office setting and to use standard office equipment, including a computer.
• Must be able to lift frequently lift up to 35 pounds and occasionally lift/move 50 pounds