General Manager - Engineering & Projects
- Hyderabad, IN
2022-09-22 17:04:13 UTC
PopVax is an Indian biotechnology company based in Hyderabad building a novel thermostable, low-cost, and safe second-generation mRNA platform for rationally-designed broadly-protective multi-epitope vaccines. We’re starting with a 4-8 °C refrigerator-stable booster vaccine candidate that is intended to protect against the entire sarbecovirus sub-family, including current and future strains of SARS-CoV-2 (the virus which causes COVID-19), and some other beta-coronaviruses such as MERS-CoV.
We’re looking for an exceptional facilities engineer and project manager with at least 10 years of experience in cGMP manufacturing to help design, build, qualify, and operationalize our new state-of-the-art mRNA-LNP manufacturing facility that we’re building from scratch near Hyderabad, then subsequently build and lead the engineering team for that facility and others that we intend to build in the future.
10+ years of experience in cGMP facility and process engineering, preferably for vaccines or other biologics, and ideally for US FDA-qualified facilities and processes
Experience managing the design, planning, buildout, qualification, and ongoing maintenance of greenfield and brownfield cGMP manufacturing projects, ideally for vaccines or other biologics, including end-to-end utilities and process engineering
Deep understanding of HVAC for Clean Rooms in cGMP facilities, including specification, AHU zoning, ducting design, installation, comissioning, qualification, and ongoing maintenance
Deep understanding of water (including WFI) and electrical systems, both generation and distribution, for cGMP facilities, including, specification, design, installation, comissioning, qualification, and ongoing maintenance
Extensive experience with BSL-2 facilities, and ideally experience with BSL-3 facilities as well
Strong understanding of and practical experience with global regulatory norms, with a focus on compliance with cGMP regulations and guidelines both in India and the US (21 CFR)
Extensive experience with facility audits, certainly as the audited party, and ideally as the auditor as well in case of outsourcing manufacturing, leasing a facility, or working with a partner
Experience setting up or running a GMP complaint handling system
Experience with modern process automation systems
Understanding of 21 CFR Part 11 compliance and experience with software related to such compliance
Proficiency with modern CAD software and other relevant design tools
Experience in vendor management for equipment, construction, engineering, maintenance, and environmental monitoring, including task specification, tender preparation, potential supplier identification, proposal review, and ongoing oversight
Experience with choosing, commissioning, qualifying, and maintaining BMS systems for cGMP manufacturing setups and QC labs
Exceptional oral and written communication skills, with the ability to conceptualize and produce comprehensive reports on the state of a project or specific systems rapidly and independently
Experience with setting up ABSL-2/3 animal houses would be a significant plus
We offer very competitive compensation, comprehensive health insurance covering immediate family (including pre-existing conditions), and, most importantly, a collaborative work environment focused on solving the cutting-edge multidisciplinary challenges of our novel mRNA platform.