What are the responsibilities and job description for the Enzene - Validation Engineer position at 1130.Works?
Job Description
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
We are seeking a skilled and experienced Validation Engineer to be responsible for performing 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
Qualifications
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.
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
We are seeking a skilled and experienced Validation Engineer to be responsible for performing 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
- Validation Activities: Conduct validation activities in accordance with company goals and regulatory requirements.
- ASTM E2500 Compliance: Perform validation activities following ASTM E2500 methodology, focusing on risk-based approaches.
- Computer System Validation (CSV): Assist in the implementation and maintenance of CSV for electronic systems, ensuring adherence to FDA regulations and industry standards.
- Cleaning Validation: Support the development and execution of cleaning validation programs to meet cleanliness standards and prevent cross-contamination.
- Project Support: Assist in managing validation projects, ensuring timely completion and adherence to project timelines and budgets.
- Documentation: Develop, review, and maintain validation documentation, including protocols, reports, SOPs, and risk assessments.
- Regulatory Compliance: Ensure compliance with GMP regulations and relevant industry standards.
- Continuous Improvement: Identify and suggest opportunities for process improvements and best practices in validation activities.
- Cross-Functional Collaboration: Collaborate with other departments, including Quality Control, Manufacturing, Engineering, and Regulatory Affairs, to ensure successful validation outcomes.
- Audits and Inspections: Support internal and external audits and inspections, providing validation documentation and addressing any findings related to validation activities.
- Site Start-Up: Assist in validation activities for site start-up, including commissioning and qualification of new facilities and equipment.
Qualifications
- Education: Bachelor’s degree in Engineering, Life Sciences, or related field.
- Experience: 3-5 years of experience in validation within the pharmaceutical or biotechnology industry, with a focus on GMP biosimilars.
- Skills: Understanding of GMP regulations, ASTM E2500, CSV, cleaning validation, and risk-based validation approaches. Strong project management, organizational, and communication skills.
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.