Computer System Validation Engineer - Libertyville, United States - On-Board Companies

Description

On-Board Services is hiring a Computer System Validation Engineer in Libertyville, IL For immediate consideration please send your resume to

Subject Line:
Position Title and State you areLocated

About Us:

On-Board Services, Incorporated is an on-site contract service provider for a local manufacturing entity providing full time positions to our employees.

We offer benefits as well as 401k.


Position Details:

Position Type:
Full Time/Contract

Job Location:
Libertyville, IL (100% on-site)

Benefits:
Health Insurance (Medical, Dental, Vision), Life Insurance, 401(k)

Compensation:
$ $61.00 per hour


Overview/Summary:

The Computer System Validation Engineer 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 AND 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 COMPETENCIES:

Knowledge, Skills, and Abilities:
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).

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).
Apply Today

On-Board was founded in 1976 by Robert L. Wilson to provide Engineering and Design services to the chemical manufacturing industry.

Today, On-Board is a thriving privately held family of companies with services including:

Consulting, Professional Engineering, Industrial Maintenance and Facility Management, Contracted Manufacturing and Production Services, as well as Temporary Staffing and Recruiting throughout North America.

The On-Board Family of Companies conducts operations through its Corporate Headquarters located in East Windsor, NJ along with Regional Offices in New Castle, DE and Wake Forest, NC.

On-Boards Mission is to provide Flexible Service by applying the talents of our people, work processes and technology to meet our clients expectations in a Safe, Responsible and Dependable manner.

On-Board Companies provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, religion, sex, national origin, age, disability or genetics.

INDE
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