Computer System Validation Engineer

Immediate need for a talented Computer System Validation Engineer. This is a 12 months Contract opportunity with long-term potential and is located in Libertyville - Innovation Way, IL (Onsite). Please review the job description below and contact me ASAP if you are interested.
Job ID: 24-12274

Pay Range: $45 - $57/hour. Employee benefits include, but are not limited to, health insurance (medical, dental, vision), 401(k) plan, and paid sick leave (depending on work location).

Key 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-Client.
• 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 Client 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.

Key Requirements and Technology Experience:

• Ability to effectively communicate with both technical and non-technical team members.
• Strong interpersonal skills, especially regarding team work, client focus, verbal and written communication
• Knowledge of industry standard Quality and Compliance methodology to ensure our IT systems deliver the intended performance and ensure they meet regulatory requirements.
• Knowledge of cGMP, GXP, GAMP, SDLC regulations, including 21CFR part 11, and good documentation practices.
• Knowledge of pharmaceutical, manufacturing and laboratory systems and equipment that support Biologics and clinical manufacturing.
• Knowledge of IT service management platforms to support incident, problem and change IT operational events (i.e. Client).
• Knowledge and exposure to Business Quality Management Systems (i.e. Veeva).
• Strong technical and problem-solving skills and the ability to work independently.
• Demonstrated success working in a high-performing, business results-driven environment.
• Understanding of computer system validation.
• Familiarity with MES systems (i.e. Emerson Syncade), DCS systems (i.e. Emerson DeltaV, ERP systems (i.e. SAP or Oracle), EBRs (i.e. InfoBatch) and Historians (i.e. OSIsoft PI).
• Understanding of computer system validation (CSV).
• 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.
• 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).

Our client is a leading Pharmaceutical industry and we are currently interviewing to fill this and other similar contract positions. If you are interested in this position, please apply online for immediate consideration.

Pyramid Consulting, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.