Validation Engineer II

Medvacon Life Sciences • East Windsor, NJ

1d

About The Position

The Validation Engineer II ensures compliance and operational excellence by managing validation processes across sterile and non-sterile manufacturing. It oversees multiple projects, develops documentation, and collaborates with teams to enhance efficiency, support product development, and drive continuous improvement aligned with our mission to provide high-quality, accessible medications.

Requirements

• Bachelor of Science degree in a scientific or engineering discipline.
• 7 years Validation experience in the pharmaceutical or biotechnology industries.
• Advanced knowledge of cGMP, CQV, sterilization process validation, and regulatory compliance, including Good Automated Manufacturing Practice and 21 Code of Federal Regulations Part 11.
• Strong problem-solving, project management, and attention to detail, with proficiency in Microsoft Office Suite, Quality Management Systems, and experience in Computer System Validation and Cleaning Validation preferred.

Nice To Haves

• Certified Quality Engineer Preferred.

Responsibilities

• Manages the full lifecycle of Computer System Validation, qualifying facilities, equipment, and processes, and developing key validation documentation, including Factory Acceptance Testing, Site Acceptance Testing, Installation Qualification, Operational Qualification, Performance Qualification, and Process Qualification for sterile and non-sterile manufacturing.
• Oversees multiple validation projects, ensuring timely budget-compliant completion while driving continuous improvement to boost manufacturing efficiency.
• Prepares, reviews, and approves technical documents, including Standard Operating Procedures and current Good Manufacturing Practice (cGMP) records, while managing change control, Corrective and Preventive Action, and quality investigations.
• Operates and manages critical equipment, executing cleaning, sterilization, and lyophilization cycles.
• Provides training, supports Research and Development and product development, manages contractors for Commissioning, Qualification, and Validation (CQV) activities, and assists with audits to ensure compliance.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 1-10 employees