Computer Systems Validation
Sequence Inc. is a total quality solutions provider to Pharmaceutical, Biotech, Life-Science industries. United with our clients, we strive to provide services that result in deliverables of the highest quality. Through our knowledge, experience, and integrity we offer a level of service that is unsurpassed industry-wide (full-lifecycle). We specialize in providing excellence in Validation, Quality and Compliance, Data Architecture & Analytics, Laboratory Informatics, Cold Chain & Facility Monitoring, Engineering, Integration & Automation, and Construction Management.
At Sequence Inc., our employees embody core values that strengthen our culture and guide our overall success. The ability to maintain a selfless attitude creates a respectful environment where ideas are shared and valued. Our teams possess the technical proficiency to do the work and the Aptitude to continue learning, growing and stretching their potential. Our unstoppable Initiative and willingness to get things done using new ideas grows our capabilities and drives our future achievements.
We are currently seeking entry-junior level Computer Systems Validation Professionals on a full-time only basis (salaried with benefits) to act as hands-on Consultants for our Southeast Quality and Compliance Service Group (IT Quality) to be responsible for projects in systems validation as they relate to the biomanufacturing, biotech, and other regulated industries (GAMP5). This position may require travel for specific projects with opportunity to grow and work locally, primarily within the greater Raleigh-Durham area (NC). The majority of projects are within the pharmaceutical industry, with potential for medical devices, general manufacturing, and agriculture. Candidates with direct experience in the valdiation of computer systems in a regulated industry will be given top priority for this role. Persons will be responsible for the day-to-day management of their specific project activities and deliverables, including, but not limited to:
Essential Functions and Responsibilities:
- Attending to clients as a full support solution to quality and compliance
- Daily management of project activities and deliverables
- Full-lifecycle qualification (IQ/OQ/PQ) and validation of systems
- Providing Regulatory Guidance regarding compliance with intended specifications
- Validation documentation creation and development including GxP Assessments, Validation Plans, Risk Assessments, Requirements/Design/Functional Specifications, IQ/OQ/PQ Protocols, Reports, Traceability Matrix, and Standard Operating Procedures
- Test Execution and Deviation Management
- Planning and scheduling of validation and Validation Lifecycle deliverables
- Implement data management and/or acquisition software
- Direct experience in the validation of computer systems
- Ability to develop and manage strong relationships
- Knowledge and utilization of regulatory compliance standards and quality assurance within regulated industries, with the ability to understand our clients' business and offer impactful solutions fit to their needs
- Understanding of the full IQ/OQ/PQ and Validation Life Cycle (GAMP5)
- Knowledge of GxP, GAMP, CFR’s (Part 11, 210, and 211)
- Exceptional communication and organizational skills
- Willingness to update and maintain knowledge by participating in educational opportunities and maintaining personal networks
- A bachelor’s degree from an ABET accredited institution in a life sciences, computer sciences, or related discipline, OR equivalent 4 years of experience as it relates to the job description
- Consultant I: 1-3 years of applicable CSV work experience in the pharmaceutical or biotechnology industry
- Consultant II: 4-7 years of applicable CSV work experience in the pharmaceutical or biotechnology industry
- Senior Consultant: 8+ years of applicable CSV work experience in the pharmaceutical or biotechnology industry
- Principal Consultant: 10+ years of applicable CSV work experience in the pharmaceutical or biotechnology industry
- Understanding of the Qualification/Validation Lifecycle (GAMP 5)
- Understanding of GxP, GAMP, CFR’s as they relate to validation
- Understanding of how to apply SOPs, work instructions, and regulatory requirements to the validation
- Understanding of Data Integrity concepts
- Experience in Laboratory Qualification/Validation is a plus
Our consultants must be knowledgeable and willing to go the extra mile in the service of a client, your success is our success. Here are some of the Benefits we offer:
- Competitive Pay
- A Three-Week Training Program
- Medical, Dental, and Vision Insurance
- Employer-paid long-term disability and short-term disability
- Maternity and Paternity
- A $50,000 team member only life insurance & ADD policy
- 401k plan with employer contributions
- Generous PTO/ Time off
- Bonus Plan
- Reimbursable Expenses (Phone, Internet, and Mileage to Client Site)
We value our employees, and beyond the great pay and benefits we offer, we care most about offering career opportunity. We are a rapidly growing consulting firm and would love to discuss the prospect of you joining our team. Sequence Inc. is proud to provide Equal Employment Opportunities, EOE/M/F/D/V, to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.
Candidates who are currently employed by a client of Sequence or an affiliated Sequence business may not be eligible for consideration.
We are unable to sponsor at this time.
Equal Opportunity Employer, including disabled and veterans.
- Pay Type Salary
- 2500 Gateway Centre Blvd, Morrisville, NC 27560, USA