Position Type: Permanent

Location: Rockville, MD, 20850, USA

Job ID#:

Position Type: Permanent
Salary Range / Rate: $90K/yr-$140K/yr (USD)

We are seeking a GxP IT Infrastructure and System Manager/Sr. Manager to join our team. He or she will play a pivotal role in establishing and maintaining Data Integrity, network security procedures regarding computer systems, ensuring consistent computer systems performance. This role will be also responsible for day-to-day IT operations activities.

Responsibilities and Duties:

• Manage and maintain essential IT operations, including operating systems, security tools, applications, servers, email systems, laptops, desktops, software, and hardware.

• Oversee and determine timeframes for major IT projects including system updates, upgrades, migrations, and outages.

• Work with internal teams to understand strategy and business challenges to proactively recommend IT solutions to deliver key programs and projects for the site, such as ERP, LIMS, etc.

• Developing and implementing IT policy and best practice guides for the organization

• Ensure all computerized system controlled and managed in accordance with GxP, GDP, and SOX requirements

• Ensure the systems are protected from acts of accidental or deliberate manipulation, modification or any other activities that may impact data quality and integrity

• Maintain the inventory of all computerized systems

• Maintain the list of normal and administrative users with defined roles and privileges

• Ensure audit trail or system logs for critical systems

• Establish the data storage and backup procedures

• Set up the disaster recovery procedure

• Establish the data archiving procedure, including accessing and reading archived data

• Perform periodic review on the computer systems, including deviations, changes, upgrade history, performance and maintenance

• Upgrade operating systems and network components in a timely manner, including applying security patches.

• Ensure the data is transferred or migrated to secure location or database through controlled and validated interface

• Maintain the system security, configure and enforce user access control procedure to prohibit unauthorized access to, changes to and deletion of data, change of validated setting and network

• Establish the procedure for the proper use of storage devices for GMP purposes, for example USB memory sticks and server or cloud-based storage solution.

• Establish the procedure of audit trails on computer systems using risk-based approach.

• Manage the day-to-day IT activities.

• Other duties as assigned

Qualifications and Requirements:

• Bachelor’s degree in technology or computer science

• At least 5 years of relevant and progressive experience driving process improvement and systems implementations and leading projects from design, development to implementation of IT solutions.

• Experience in biotech, pharma or life sciences manufacturing and lab with an understanding of what is required in a GMP environment is a must.

• Expertise with implementing, configuring, and testing solutions.

About Us:

Founded in 2009, IntelliPro is a global leader in talent acquisition and HR solutions. Our commitment to delivering unparalleled service to clients, fostering employee growth, and building enduring partnerships sets us apart. With a dynamic presence in the USA, China, Canada, Singapore, Philippines, UK, India, Netherlands, and Germany, we continue leading global talent solutions.
IntelliPro, a global leader connecting individuals with rewarding employment opportunities, is dedicated to understanding your career aspirations. As an Equal Opportunity Employer, IntelliPro values diversity and does not discriminate based on race, color, religion, sex, sexual orientation, gender identity, national origin, age, genetic information, disability, or any other legally protected group status. Moreover, our Inclusivity Commitment emphasizes embracing candidates of all abilities and ensures that our hiring and interview processes accommodate the needs of all applicants. Learn more about our commitment to diversity and inclusivity at https://intelliprogroup.com/.