Job Information
Belcan Validation Engineer in New Albany, Ohio
Validation Engineer
Job Number: 350287
Category: Industrial Engineering
Description: Job Title: Validation Engineer
Pay Rate: $56.50/ hr
Location: New Albany, OH
ZIP Code: 43054
Start Date: Right Away
Keywords: #Validation Engineer #Engineering
Benefits:
Medical / Health Benefits with multiple plan options, Flexible Spending Accounts, Dental and Vision / glasses / prescription contact lens and eye test options available.
On the job training / cross-training to develop and expand skills, creating opportunity for advancement and personal development. Tuition reimbursement available for relevant development opportunities.
Life Insurance, disability insurance, and voluntary life insurance for family members available. Accident and critical illness insurance optional.
Scheduled performance reviews create opportunities for advancement and pay increases.
We have many success stories from individuals who took advantage of the training, cross-training, and personal development opportunities for advancement. We also have success stories of individuals who desired a reliable, scheduled and consistent career with appropriate work-life balance, health benefits and good job security. Whichever way you define success, this work culture cares about team members and treats each individual with dignity, inclusion, respect and recognition.
A Referral Program compensates active employees for referring friends and former colleagues when the referral results in hiring the person. Our team has grown with referrals and internal promotions.
Responsibilities:
Onsite New Albany, OH - must be local (not willing to look at someone who will need to relocate at this time)
6 months initial contract with extension
Standard business hours- 8 AM - 5 PM
Primarily responsible for ensuring adherence to computer validation standards and procedures for computer related systems. Responsibilities include participation in system design, preparation of test protocols, analysis of test results and preparation of summaries. Provides guidance and sets standards in producing quality documentation, serves as the liaison between the IS and Quality functions, provides testing and IT compliance guidance, and provides timely and effective response and follow-through in the resolution of IT Quality/Project compliance issues.
This role is for a strong background in IT Business systems validation, IT Automation systems validation, ensuring that our Information technology systems and processes meet regulatory requirements and industry standards, particularly within the framework of GxP (Good manufacturing Practice) in projects. Integrates a variety of systems technologies to provide systems related solutions to meet business needs. Supports the creation and maintenance of a Amgen Ohio's computer systems validation.
Perform Deviations, CAPA, Change records for DTI computer systems (E.g: MES, SCADA, ASRS, ServiceNow, QBAS, SAP/ERP, Serialization, etc).
Provide support to system owners on completing Design Spec, URS, Traceability, IQ (Installation Qualification), OQ (Operational Qualification), PQ (Performance Qualification) draft copies.
Provide support on completion of validation deliverables as required per the project.
Develop and execute test scripts in ALM, Kneat test tools to support system owners/IT Application Owners.
Ensure and track computer systems periodic reviews and periodic access reviews are completed as per schedule to maintain system maintenance phase.
Ensures that systems are maintained in a compliant manner according to the DTI quality systems standards.
Support regulatory inspections and internal audits as required.
Academic/Technical Qualifications:
Bachelor"s Degree in a science or Engineering discipline required.
5+ years relevant experience in computer system validation (E.g: MES, SCADA, Building Management system (BMS, QBAS), Serialization, QC systems).
Technical / Knowledge:
Experience with ALM or Kneat testing tool is plus.
Experience with ServiceNow, Track wise (CAPA, Deviations), Veeva document management, CAPA, Deviations, Change Management.
Knowledge of cGMP regulations and guidelines including but not limited to U.S. code of Federal Regulations 21 CFR Part 11 and Part 211.
Understanding of industry standards and best practices for computer system validation such as GAMP 5.
If you are interested in this role, please apply via the apply now link provided. Our overriding goal is to provide quality staffing solutions that help people, organizations, and communities succeed. Belcan is a leading provider of qualified personnel to many of the world's most respected enterprises. We offer excellent opportunities for contract, temporary, temp-to-hire, and direct assignments. We are the employer of choice for thousands worldwide. For more information, please visit our website at Belcan.com
EOE/F/M/D/V
Location: New Albany , OH
Minimum Experience (yrs):
Required Education: Not Specified
Benefits:
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