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Validation Engineer

3-5 years
Not Disclosed
10 Jan. 2, 2025
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Validation Engineer
Company: Enzene
Location: Hopewell, New Jersey, United States

About Enzene
Enzene Inc. is a Contract Development and Manufacturing Organization (CDMO) with a strong operational presence in India. As a subsidiary of Enzene Biosciences, a leading biotechnology company, Enzene is committed to providing high-quality biologics manufacturing services to clients and advancing the pharmaceutical industry.

Website: www.enzene.com

Position Overview
Enzene is seeking an experienced and skilled Validation Engineer to 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. The Validation Engineer will also support validation activities related to site start-up, including commissioning and qualification of new facilities, utilities, and equipment.

Key Responsibilities

  • Validation Activities: Conduct validation in line with company objectives and regulatory requirements.
  • ASTM E2500 Compliance: Implement validation activities according to ASTM E2500 methodology, utilizing risk-based approaches.
  • Computer System Validation (CSV): Assist with the implementation and maintenance of CSV for electronic systems, ensuring compliance with 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: Manage validation projects, ensuring timely completion, adherence to timelines, and budget compliance.
  • Documentation: Develop, review, and maintain validation documentation, including protocols, reports, SOPs, and risk assessments.
  • Regulatory Compliance: Ensure adherence to GMP regulations and relevant industry standards.
  • Continuous Improvement: Proactively identify opportunities for process improvements and validation best practices.
  • Cross-Functional Collaboration: Work closely with other departments, including Quality Control, Manufacturing, Engineering, and Regulatory Affairs, to ensure successful validation outcomes.
  • Audits and Inspections: Support internal and external audits, providing validation documentation and addressing findings.
  • Site Start-Up: Assist with validation activities for new facility start-ups, including commissioning and qualification of facilities and equipment.

Qualifications

  • Education: Bachelor’s degree in Engineering, Life Sciences, or a related field.
  • Experience: 3-5 years of validation experience in the pharmaceutical or biotechnology industry, with a focus on GMP biosimilars.
  • Skills: Knowledge of GMP regulations, ASTM E2500, CSV, cleaning validation, and risk-based validation approaches. Strong organizational, project management, and communication skills.

Why Join Enzene?
At Enzene, we foster a collaborative and innovative environment where science and business intersect. Our team is dedicated to advancing biosimilar manufacturing and continuously improving processes and patient outcomes. Joining Enzene means becoming part of a company that values integrity, innovation, and collaboration in pursuit of scientific excellence.

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