Enzene - Validation Engineer

About Our Client - Enzene
Enzene Inc. is an emerging Contract Development and Manufacturing Organization (CDMO) with a strong operational footprint in India. We are a subsidiary of Enzene Biosciences, a leading biotechnology company. Our mission is to provide high-quality biologics manufacturing services to our clients, contributing to the advancement of the pharmaceutical industry.

Website: www.enzene.com

Position Overview
The Validation Engineer will perform validation activities for our facility, utilities, manufacturing, and analytical equipment, ensuring compliance with GMP regulations, ASTM E2500 methodology, Computer System Validation (CSV), and cleaning validation. Additionally, the Validation Engineer will support validation activities associated with site start-up, including commissioning and qualification of new facilities, utilities, and equipment.

Key Responsibilities

• Site Start-Up and Routine Validation Activities: Support validation activities for site start-up, including commissioning and qualification of new facilities, utilities, equipment, and systems, ensuring readiness for full-scale manufacturing operations while ensuring all activities are conducted following company goals and regulatory requirements.
  
• ASTM E2500 Compliance: Perform validation activities following ASTM E2500 methodology, focusing on risk-based approaches and ensuring critical quality attributes are controlled.
  
• Computer System Validation (CSV): Assist in the implementation and maintenance of CSV for electronic systems, ensuring adherence to FDA regulations, 21 CFR Part 11, Annex 11, and industry standards, while authoring and executing CSV protocols, reports, and ensuring data integrity
  
• Cleaning Validation: Develop, execute, and maintain cleaning validation programs, including periodic requalification, ensuring cleanliness standards, and preventing cross-contamination following regulatory expectations.
  
• Project Support: Assist in managing multiple and complex CQV projects, providing status reports, and coordinating with internal departments and external contractors/vendors to ensure timely and compliant project execution, while ensuring all project deliverables meet regulatory standards.
  
• Documentation: Develop, review, own, and maintain validation documentation, including CQV protocols, summary reports, SOPs, risk assessments, project plans, master plans, FMEAs, ensuring conformance to regulations, data integrity, and company SOPs
  
• Regulatory Compliance: Ensure compliance with GMP regulations and relevant industry standards by executing, owning, and assessing validation protocols, participating in change controls, and ensuring all validation activities align with FDA, and relevant industry guidelines.
  
• Continuous Improvement: Identify, develop, and propose opportunities for process improvements in validation activities, ensuring enhanced efficiency, quality, and regulatory compliance across all CQV processes.
  
• Cross-Functional Collaboration: Collaborate with Quality Control, Manufacturing, Engineering, Regulatory Affairs, and external contractors to ensure successful validation outcomes, manage project timelines, and resolve technical challenges.
  
• Audits and Inspections: Support internal and external audits and inspections by preparing and providing comprehensive validation documentation and addressing any findings related to validation activities.
  
• Technical Support and CAPA Management: Support and/or own technical and quality investigations, CAPAs, and corrective actions related to validation activities, ensuring timely resolutions, accurate documentation, and regulatory compliance.
  
• Risk and Change Management: Participate in authoring and executing risk assessments, including FMEAs and periodic qualifications, managing and reviewing change controls, and ensuring all changes comply with regulatory standards and company SOPs.

Qualifications

• Education: Bachelor’s degree in Engineering, Life Sciences, or related field.

• Experience: 5 or more years of experience in validation within the pharmaceutical or biotechnology industry. Experience with GMP biosimilars is an asset. Understanding of GMP regulations, ASTM E2500, CSV, cleaning validation, and risk-based validation approaches. Relevant certifications in validation or quality assurance are a plus.

• Skills: Strong project management, organizational, and communication skills with the ability to manage multiple ongoing projects independently. Strong interpersonal and teamwork skills, capable of working in cross-functional teams and fast-paced environments with minimal supervision. Excellent attention to detail, ability to follow procedures, summarize and present results, and contribute to team-based collaborations. Proficiency in Microsoft Office applications (Outlook, Excel, Word, and PowerPoint).

Why Join Enzene?

At Enzene, we foster a collaborative and innovative environment where science and business intersect. Our team is dedicated to pushing the boundaries of biosimilar manufacturing, and we are constantly striving to improve processes and patient outcomes. Joining Enzene means being part of a company that values integrity, innovation, and collaboration in pursuit of scientific excellence.

We offer an environment of growth, learning, and opportunity in a sector that is driving change in healthcare.

Equal Opportunity Employer
Enzene is an equal opportunity employer, committed to fostering a diverse and inclusive work environment where all employees can thrive.