Computer System Validation Engineer

Company: Innova
Location: Libertyville
Posted on: February 12, 2025

Job Description:

Innova Solutions has a client that is immediately hiring for a Computer System Validation Engineer

Increase your chances of reaching the interview stage by reading the complete job description and applying promptly.



Position type: Full-time Contract

Duration: 12 months

Location: Libertyville, IL



As a Computer System Validation Engineer you will:



Job Description:

Support the IT Quality & Compliance for the Cell Therapy manufacturing site.
Take ownership of deviations, CAPAs and investigations involving the Manufacturing IT Systems.
Open and lead investigations, triage deviations, and ensure CAPAs are addressed and implemented per requirements.
Engage technical experts as needed to author and present change requests and author investigations write-ups.
Support Health Authority and internal audits.
Collaborate and support the other Site IT groups (Manufacturing IT Systems & MES, Operational Technology Systems & Automation, Enterprise Systems and Integration, IT Site Shared Services) to ensure we can correctly support the manufacturing site.
Gain proficiency in the IT Service Management platform ServiceNow to create and track service requests, incidents, requests, problems, etc.
Provide support for operationalizing the manufacturing and peripheral systems.
Responsible for Computer System Validation of local/site-based systems
Accountable for the continued compliance of IT systems, procedures and training for vector manufacturing and lab systems.

The ideal candidate will have:

Bachelor's degree in an engineering or MIS discipline.
Must have experience with IT Quality & Compliance applications and systems in a bio-tech manufacturing environment.
Must have 5+ years of hands-on experience in a biotech manufacturing and supply chain environment.
Knowledge of cGMP, GXP, GAMP, SDLC regulations, including 21CFR part 11, and good documentation practices
Knowledge and experience in utilizing Change Management Applications i.e. ServiceNow, Infinity, Veeva, Valgenesis,
Experience in leading investigations and initiating deviations and Change Control activities.
Working knowledge of regulatory requirements and how they relate to existing and new business systems and practices, primarily GxP.
Understanding of computer system validation and experience using IT service management platforms (QMS) to support incident, problem and change IT operational events (i.e. ServiceNow, Infinity).
Familiarity with DCS systems (i.e. Emerson DeltaV, Rockwell SCADA, ERP systems (i.e. SAP or Oracle), and Historians (i.e. OSIsoft PI).

Qualified candidates should APPLY NOW for immediate consideration! Please hit APPLY to provide the required information, and we will be back in touch as soon as possible.

We are currently interviewing to fill this and other similar positions. If this role is not a fit for you, we do offer a referral bonus program for referrals that we successfully place with our clients, subject to program guidelines. ASK ME HOW.



Thank you!

Aritra Roy

4702230481

Aritra.Roy@innovasolutions.com



PAY RANGE AND BENEFITS:

Pay Range*: $ 63.00 - $ 65.00 per hour

*Pay range offered to a successful candidate will be based on several factors, including the candidate's education, work experience, work location, specific job duties, certifications, etc.



Benefits: Innova Solutions offers benefits( based on eligibility) that include the following: Medical & pharmacy coverage, Dental/vision insurance, 401(k), Health saving account (HSA) and Flexible spending account (FSA), Life Insurance, Pet Insurance, Short term and Long term Disability, Accident & Critical illness coverage, Pre-paid legal & ID theft protection, Sick time, and other types of paid leaves (as required by law), Employee Assistance Program (EAP).



ABOUT INNOVA SOLUTIONS: Founded in 1998 and headquartered in Atlanta, Georgia, Innova Solutions employs approximately 50,000 professionals worldwide and reports an annual revenue approaching $3 Billion. Through our global delivery centers across North America, Asia, and Europe, we deliver strategic technology and business transformation solutions to our clients, enabling them to operate as leaders within their fields.



Recent Recognitions:

Named One of America's Best Employers for New Grads by Forbes (2024
Named One of the Best Companies to Work For by U.S. News & World Report (Private Companies List, 2024-2025)
One of the Largest IT Staffing Firms in the US - Ranked #3 by Staffing Industry Analysts (SIA, 2024)
One of the Largest Staffing Firms in the US - Ranked #13 by Staffing Industry Analysts (SIA, 2024; includes Innova Solutions, Volt, & HireGenics)
Named One of the Top Ten Private Companies in Atlanta by the Atlanta Business Chronicle (2023)
One of the Largest Certified Minority Business Enterprises (MBEs) in the United States (NMSDC, 2024)
AWS Advanced Tier Services Partner with 100+ certifications



Website: https://www.innovasolutions.com/



Innova Solutions is an Equal Opportunity Employer and prohibits any kind of unlawful discrimination and harassment. Innova Solutions is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment on the basis of race, color, religion or belief, national origin, citizenship, social or ethnic origin, sex, age, physical or mental disability, veteran status, marital status, domestic partner status, sexual orientation, or any other status protected by the statutes, rules, and regulations in the locations where it operates. If you are an individual with a disability and need a reasonable accommodation to assist with your job search or application for employment, please contact us at hr@innovasolutions.com or (770) 493-5588. Please indicate the specifics of the assistance needed. Innova Solutions encourages all interested and qualified candidates to apply for employment opportunities. Innova Solutions (HireGenics/Volt) does not discriminate against applicants based on citizenship status, immigration status, or national origin, in accordance with 8 U.S.C. - 1324b.

The company will consider for employment qualified applicants with arrest and conviction records in a manner that complies with the San Francisco Fair Chance Ordinance, the Los Angeles Fair Chance Initiative for Hiring Ordinance, and other applicable laws.

Keywords: Innova, Chicago , Computer System Validation Engineer, IT / Software / Systems , Libertyville, Illinois