Validation Engineer

4 weeks ago

Foster City, United States Volt Full time
Innova Solutions has a client that is immediately hiring for a Validation Engineer III.
  
Position type:               Full-time - Contract
Duration:                         12 Months
Location:                         Foster City, CA
 
As a Validation Engineer III, you will:
 
Description
 
Job Responsibilities:
  • Responsible for authoring and/or revising the following documents related to GxP Systems (specifically GE iFix & Rockwell FactoryTalk View based Environmental Monitoring Systems): User Requirements Specification, Functional Requirements Specification, Design Specification, Configuration Specification, Trace Matrix, Requirements Risk Assessment, Installation, Operational and Performance Qualification protocols. Responsible for execution of authored protocols.
  • Author change management records, create or revise impacted documentation and execute change implementation tasks.
  • Develop decommissioning and data migration strategies for legacy systems and author validation deliverables for decommissioning systems.
  • Collaborate with cross-functional teams in authoring CAPAs and Deviations.
  • Perform periodic system maintenance activities such as, account management, system maintenance, system audit trail review and backup and restore testing, etc.
  • Maintain system specific operational documentation such as SOPs, work instructions, business-enabling documents, training plan as well as contribute to authoring and maintenance of business SOPs.
  • Coordinate with IT stakeholders for maintenance of system infrastructure, security, and vulnerability management.
  • Coordinate with business stakeholders to constantly align with their needs and deliver technical and compliant solutions, as required.
  • Coordinate with software vendors for change deployment, scheduling of system maintenance activities and issue management.
 
Education:
Bachelor's degree.
 
Experience:
  • Minimum 5 years of experience working in an FDA regulated environment, validating computerized systems. System Administration experience is preferred but not required.
  • Must be experienced in computer system validation using GAMP 5 methodology.
  • Must have a good understanding of 21 CFR part 11 and Annex 11 and how these regulations relate to environmental monitoring systems.
  • Experienced in developing validation methodology for global implementation of systems.
  • Experience with validation methodologies and SDLC best practices.
  • Proficient in current Good Manufacturing Practices (cGMPs) requirements.
 
Required Years of Experience: 5
 
Top 3 Required Skill Sets:
Computer system validation using GAMP 5 methodology
21 CFR part 11 and Annex 11
Change Control and Impact Assessments
 
Top 3 Nice to Have Skill Sets:
Process Control Systems / Environmental Monitoring Systems technical proficiency
Data Migration experience
Project Management
 
Unique Selling Point of this role:
Computer system validation expertise with experience in validating a variety of computer systems.
 
Required Degree or Certification
Bachelor's degree in computer science or Pharma/Biotech related field
 
Qualified candidates should APPLY NOW for immediate consideration Please hit APPLY to provide the required information, and we will be back in touch as soon as possible.
 
We are currently interviewing to fill this and other similar positions. If this role is not a fit for you, we do offer a referral bonus program for referrals that we successfully place with our clients, subject to program guidelines. ASK ME HOW.
 
Thank you
Pradip Joshi
Email - Pradip.Joshi@innovasolutions.com
Phone: 213-401-2633
 
PAY RANGE AND BENEFITS:
 
Pay Range*: $65- $70/Hr
 
*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:
  • Named One of America's Best Employers for New Grads by Forbes (2024
  • Named One of the Best Companies to Work For by U.S. News & World Report (Private Companies List, 2024-2025)
  • One of the Largest IT Staffing Firms in the US Ranked #3 by Staffing Industry Analysts (SIA, 2024)
  • One of the Largest Staffing Firms in the US Ranked #13 by Staffing Industry Analysts (SIA, 2024; includes Innova Solutions, Volt, & HireGenics)
  • Named One of the Top Ten Private Companies in Atlanta by the Atlanta Business Chronicle (2023)
  • One of the Largest Certified Minority Business Enterprises (MBEs) in the United States (NMSDC, 2024)
  • AWS Advanced Tier Services Partner with 100+ certifications
 
Website: https://www.innovasolutions.com/ 
Innova Solutions is an Equal Opportunity Employer and prohibits any kind of unlawful discrimination and harassment. Innova Solutions is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment on the basis of race, color, religion or belief, national origin, citizenship, social or ethnic origin, sex, age, physical or mental disability, veteran status, marital status, domestic partner status, sexual orientation, or any other status protected by the statutes, rules, and regulations in the locations where it operates. If you are an individual with a disability and need a reasonable accommodation to assist with your job search or application for employment, please contact us at hr@innovasolutions.com or (770) 493-5588. Please indicate the specifics of the assistance needed. Innova Solutions encourages all interested and qualified candidates to apply for employment opportunities. Innova Solutions (HireGenics/Volt) does not discriminate against applicants based on citizenship status, immigration status, or national origin, in accordance with 8 U.S.C. § 1324b. The company will consider for employment qualified applicants with arrest and conviction records in a manner that complies with the San Francisco Fair Chance Ordinance, the Los Angeles Fair Chance Initiative for Hiring Ordinance, and other applicable laws.

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