Computer System Validation Engineer - Eclaro
Libertyville, IL 60048
About the Job
Computer System Validation Engineer
Job Number: 24-00891
Job Number: 24-00891
Be part of a company that delivers life-changing healthcare solutions. Eclaro is looking for a Computer System Validation Engineer for our client in Libertyville, IL.
Eclaro’s client is a leader in the Biopharmaceutical Industry, providing quality, innovative, and affordable medicines that make a difference in the lives of patients all over the world. If you’re up to the challenge, then take a chance at this rewarding opportunity!
Position Overview:
- 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.
- Responsible for development of and adherence to system governance procedures.
- 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.
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.
Required Qualifications:
- Should have at least 5+ years of experience in pharma/biotech with specific expertise in Supply Chain, Manufacturing, and Quality System disciplines.
- 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.
Required Skills:
- 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.
- 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. ServiceNow).
- 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).
- 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).
Pay Rate: $60.00/hr.
If hired, you will enjoy the following Eclaro Benefits:
If hired, you will enjoy the following Eclaro Benefits:
- 401k Retirement Savings Plan administered by Merrill Lynch
- Commuter Check Pretax Commuter Benefits
- Eligibility to purchase Medical, Dental & Vision Insurance through Eclaro
If interested, you may contact:
June Binuya
junethel.binuya@eclaro.com
2128047476
June Binuya | LinkedIn
Equal Opportunity Employer: Eclaro values diversity and does not discriminate based on Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
Source : Eclaro