Validation Engineer
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Title: Validation Engineer
Location: Foster City, CA
Duration: 12 Months 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.
Requirements:
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 Years
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
About Us: Established in 2004, SPECTRAFORCE is one of the largest and fastest-growing diversity-owned staffing firms in the US. The growth of our company is a direct result of our global client service delivery model that is powered by our state-of-the-art A.I. proprietary talent acquisition platform, robust ISO 9001:2015/ISO 27001 certified processes, and strong and passionate client engaged teams. We have built our business by providing talent and project-based solutions, including Contingent, Permanent, and Statement of Work (SOW) services to over 140 clients in the US, Canada, Puerto Rico, Costa Rica, and India. Key industries that we service include Technology, Financial Services, Life Sciences, Healthcare, Telecom, Retail, Utilities and Transportation. SPECTRAFORCE is built on a concept of human connection, defined by our branding attitude of NEWJOBPHORIA , which is the excitement of bringing joy and freedom to the work lifestyle so our people and clients can reach their highest potential. Learn more at:
Benefits: SPECTRAFORCE offers ACA compliant health benefits as well as dental, vision, accident, critical illness, voluntary life, and hospital indemnity insurances to eligible employees. Additional benefits offered to eligible employees include commuter benefits, 401K plan with matching, and a referral bonus program. SPECTRAFORCE provides unpaid leave as well as paid sick leave when required by law.
Equal Opportunity Employer: SPECTRAFORCE is an equal opportunity employer and does not discriminate against any employee or applicant for employment because of race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability or veteran status, or any other category protected by applicable federal, state, or local laws. Please contact Human Resources at if you require reasonable accommodation.
California Applicant Notice: SPECTRAFORCE is committed to complying with the California Privacy Rights Act ( CPRA ) effective January 1, 2023; and all data privacy laws in the jurisdictions in which it recruits and hires employees. A Notice to California Job Applicants Regarding the Collection of Personal Information can be located on our website. Applicants with disabilities may access this notice in an alternative format by contacting .
LA County, CA Applicant Notice: If you are selected for this position with SPECTRAFORCE, your offer is contingent upon the satisfactory completion of several requirements, including but not limited to, a criminal background check. We consider qualified applicants with arrest or conviction records for employment in accordance with all local ordinances and state laws, including the Los Angeles County Fair Chance Ordinance for Employers (FCO) and the California Fair Chance Act (FCA). The background check assessment will consider whether a criminal history could reasonably have a direct, adverse impact on the job-related safety, security, trust, regulatory compliance, or suitability for this role. Such findings may result in withdrawal of a conditional job offer.
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position's starting pay is: $60.00/hr.
