Infrastructure Engineer -GMP focused (Pharma or Medical Device experience is a must)
This independent self-starter will be asked to draft, adjust, and improve SOPs; support a predominantly Microsoft and cloud-based virtualized infrastructure, be proficient with cybersecurity, and respond to help desk requests and special projects. The goal is to increase the bandwidth of the small IT staff for this burgeoning highly technical start up in Rockville, MD by bringing significant experience in regulated IT environments.
- Install, operate and optimize on-prem virtualization environments (currently VMware ESXi 7.0), including client’s GMP virtualization infrastructure.
- Maintain Active Directory and other Windows server services (DNS, DHCP, file & print, etc.)
- Create and maintain documentation for GMP IT network operations policies and SOPs, including patching, backup, asset tracking, change management and other GMP-required IT SOPs
- Manage recurring GMP infrastructure tasks, including server patching, backups, account management and log management.
- Support client regulatory audits in conjunction with client stakeholders
- Take an active role in client’s IT change management process.
· Provide tier 2 / tier 3 support and escalation to client staff from IT Help Desk
- Assess, design, implement and optimize storage infrastructure, including backup policies and business continuity / disaster recovery planning.
- Collaborate across Functional Areas: Quality Assurance, GMP Engineering, Manufacturing and Validation teams to support regulatory compliance, including data integrity policies.
- Perform computerized system risk assessments to determine IT responsibilities and needed support.
- Assist with computer system validations (CSV) as required.
- Initiate change controls and Corrective Action/Preventative Actions (CAPAs) for GMP IT Infrastructure
- Assess, design, install, implement, and optimize IT security operations according to industry best practices, in coordination with IT team.
- Assess, design, implement and optimize internal network infrastructure according to industry best practices, in coordination with IT team.
- Bachelor’s degree in relevant field of study
- Candidates should ideally have 7-10 years of experience in a GMP-focused IT engineering role.
- Experience participating in regulatory audits and speaking to IT responsibilities and procedures.
- Virtualization and storage experience, preferably in an environment with multiple virtualization hosts, storage environments, etc. (Nimble storage experience desired)
- Office 365 / Azure administration experience, including Azure Active Directory, Exchange and InTune
- Active Directory design and administration, including group policy.
- Windows server experience (2012, 2016, 2019)
- Experience planning, implementing and testing BC/DR policies and procedures.
- Strong knowledge of data integrity requirements and 21 CFR Part 11 compliance
- Strong written and verbal communication skills
- Cybersecurity experience, including incident response, penetration testing, EDR/XDR, SIEM solutions.
- Asset management and ticketing platform implementation and administration
- Experience working in environments with an IT MSP presence.
- Microsoft, Cisco and/or VMware certifications preferred.