Validation Associate (Entry-Level Engineering Graduates Encouraged)

Role Overview

The Validation Associate plays a critical role in supporting commissioning, qualification, validation, requalification, and documentation tasks related to GMP equipment, utilities, processes, controlled environments, and supporting systems within a sterile injectable manufacturing setup. This position executes detailed protocol activities, prepares necessary validation materials and equipment, collects technical data, and maintains thorough documentation under the guidance of seasoned Validation team members. Collaboration with departments such as Manufacturing, Quality Assurance, Engineering, Facilities, Microbiology, and Quality Control is essential to uphold compliance and the validated status of processes and equipment.

Key Duties

• Carry out assigned validation, qualification, requalification, and verification protocols precisely as per approved procedures.
• Prepare validation test areas, including materials, instruments, data loggers, sample containers, forms, and other supporting documents.
• Confirm equipment identification, calibration status, instrument readiness, and the availability of materials prior to testing.
• Document, organize, reconcile, and submit validation data such as observations, test results, instrument readings, calibration records, and other evidences following Good Documentation Practices.
• Support validation operations involving facilities, utilities, manufacturing and lab equipment, cleaning and sterilization processes, controlled environments, and computerized systems as assigned.
• Detect and promptly report any discrepancies, unexpected outcomes, equipment problems, missing data, test failures, or deviations from protocols.
• Assist in validation document control, investigations, change management, deviations, CAPAs, equipment installation and commissioning, audit preparation, and maintaining validation trackers and schedules for requalification.

Candidate Profile

Experience: Candidates with 0–2 years of involvement in validation, commissioning, engineering, quality assurance, technical or laboratory roles within regulated pharmaceutical, biotech, medical device, or life sciences sectors are suitable. Internship or academic experiences related to equipment handling, testing, documentation, manufacturing, or quality practices will also be considered. Exposure to sterile manufacturing, cleanrooms, aseptic processing, utilities, equipment qualification, or pharma production is advantageous but not mandatory.

Education: Minimum qualifications include an associate degree, technical diploma, or an equivalent blend of education, training, and relevant experience. A bachelor's degree in Engineering, Life Sciences, Chemistry, Biology, Pharmaceutical Sciences, Manufacturing Technology, or closely related technical fields is strongly favored.

Knowledge & Skills: Basic familiarity with cGMP standards, Good Documentation Practices, principles of data integrity, and document control is essential. Understanding of the validation lifecycle (commissioning, IQ, OQ, PQ, requalification, change controls, deviations, CAPA) is beneficial. Ability to follow standard protocols accurately, keen attention to detail, strong organizational skills, and multi-tasking capabilities are required. Proficiency in Microsoft Office applications and preferably experience with electronic document management systems is expected.

Benefits and Compensation

• Competitive yearly base salary plus eligibility for an annual performance bonus.
• Annual merit raises based on performance.
• Automatic 401(k) enrollment with 3% pre-tax contribution and a company match of 50% on the first 6% contributed.
• Paid time off along with 10 company holidays annually.
• Comprehensive medical, dental, vision, and life insurance plans.
• Reimbursement for professional development and tuition for children, as well as childcare expense support.
• Opportunities for career advancement within the organization.

Work Schedule

This full-time position operates onsite from Monday to Friday, 8:00 AM to 5:00 PM.