About Enzene
We Are Enzene, a Continuously Innovative Development and Manufacturing (CIDMO) partner to innovators and biosimilar developers. From state-of-the-art sites in Pune, India, and Hopewell, New Jersey, we provide fully-integrated services that span discovery, development, and commercial supply.
Our innovative EnzeneX™ platform incorporates the first truly fully-connected continuous manufacturing™ (FCCM™) technology to be validated for commercial biologics supply. We are proud pioneers of next-generation biologics technologies, and disruptors of existing biologics manufacturing paradigms: accelerating time-to-market and providing the highest production yields to drive down the cost of a broad range of biologic modalities.
For more information on Enzene, please visit www.enzene.com
About the Role:
We are looking for an experienced IT Infrastructure & Information Security professional to support and manage IT infrastructure operations while ensuring compliance with regulatory and information security requirements across Enzene Biosciences Ltd.
Roles & Responsibilities:
- Support and manage IT infrastructure operations across the organization
- Analyze business processes and implement automation, best practices, and IT solutions based on business requirements
- Implement infrastructure and information security projects while identifying and mitigating project risks
- Ensure compliance with ISO 27001 and other regulatory requirements
- Implement backup solutions, OS hardening, and network/server architecture compliance
- Lead and support ISO 27001 audits, internal audits, statutory audits, and regulatory inspections
- Conduct ISO 27001 internal audits as Lead Auditor when required
- Prepare and review IT policies, SOPs, protocols, reports, and qualification documents
- Support IT infrastructure qualification activities including test scripts and validation documentation
- Prepare IT MIS reports, trend IT incidents/issues, and implement corrective actions
- Conduct IT and ISMS-related training programs for employees and contract staff
- Participate in leadership discussions and support strategic IT initiatives
Education:
- Bachelor's degree in Computer Science, Information Technology, Engineering, or related discipline
- Relevant certifications such as ISO 27001 Lead Auditor, CCNA, MCSE, VMware, or cybersecurity certifications will be preferred
Preferred Candidate:
- Experience in IT Infrastructure and Information Security within regulated industries preferred
- Strong understanding of ISO 27001, IT compliance, backup solutions, OS hardening, and server/network architecture
- Experience handling audits, regulatory inspections, and documentation activities
- Good communication and stakeholder management skills
- Exposure to GMP/GxP-regulated environments will be an added advantage
- Strong analytical and problem-solving skills
