Computer System Validation Engineer
Innova Solutions
- Libertyville, IL
- $52.00-57.00 per hour
- Contract
- Full-time
Location- Libertyville, IL--Onsite
Duration- 12 MonthsJob Details:
The Manufacturing IT Systems Quality & Compliance Specialist- Cell Therapy Manufacturing Systems supports the successful operation of manufacturing and business functions at Libertyville site through interaction with internal team members, peer and higher-level customers as well as external service providers. The individual is responsible for development of and adherence to system governance procedures. The individual supports multiple IT projects/systems and ongoing work activities of moderate to high complexity.
Reporting into the site Digital Plant organization the candidate will be primarily responsible for managing IT deviations, CAPAs, Investigations, Change Management, computer system validation in support of the vector manufacturing site.
The candidate should have at least 5+ years of experience in pharma/biotech with specific expertise in Supply Chain, Manufacturing, and Quality System disciplines. The candidate needs to understand shop floor activities, Good Manufacturing Practices (GMPs), electronic change management, and process automation in addition to prior manufacturing systems development and support.Duties & Responsibilities:
- Support the IT Quality & Compliance for the Cell Therapy Vector 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.
- 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).Education and Experience:
- Bachelors 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.
- Understanding of supply chain, manufacturing domains and supporting technology including manufacturing and supply chain ERP systems (e.g. Oracle, SAP).
- Working knowledge of regulatory requirements and how they relate to existing and new business systems and practices, primarily GxP.
- Sound understanding of Electronic Batch Records (EBR) and Review by Exception (RBE).
Vidhi Tyagi
Sr. Associate ? RecruitmentPAY RANGE AND BENEFITS:
Pay Range*: $52-$57 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:
- One of Largest IT Consulting Staffing firms in the USA - Recognized as #4 by Staffing Industry Analysts (SIA 2022)
- ClearlyRated® Client Diamond Award Winner (2020)
- One of the Largest Certified MBE Companies in the NMSDC Network (2022)
- Advanced Tier Services partner with AWS and Gold with MS