Computer Systems Validation - Winston-Salem, NC
We are currently interviewing candidates to join Sequence, Inc. as Computer Systems Validation Professionals within the Winston-Salem, North Carolina region. In this role, you will be responsible for a range of projects involving systems validation as they relate to biomanufacturing, biotech, and other regulated industries (GAMP5).
This position is intended for those who embody Sequence’s core values of selfless Attitude, Aptitude for continued learning, and unstoppable Initiative.
Do you love to travel and explore new places? This position may require travel for specific projects with the opportunity to grow and work locally, primarily within North Carolina. Most projects are within the pharmaceutical industry. If you are willing to travel out-of-state and/or temporarily relocate you will be given top priority for this role!
In this role you will be held responsible for the day-to-day management of specific project deliverables, including, but not limited to:
Position Accountabilities and Responsibilities:
- Attending to clients as a full support solution to quality and compliance
- Full-lifecycle qualification (IQ/OQ/PQ) and validation of software 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
- 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
- Exceptional communication and organizational skills
- Ability to develop and manage strong relationships
- Willingness to update and maintain knowledge by participating in educational opportunities and maintaining personal networks
- A two or four-year degree in life sciences, computer sciences, or a related discipline, OR equivalent 4 years of experience as it relates to the job description
- 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
Here are Some of the Benefits We Offer:
- Competitive Pay as a Full Time Employee
- A Three-Week Training Program with on-going training thereafter
- Generous PTO/ Time off
- Bonus Plan
- Reimbursable Expenses (Phone, Internet, and Mileage to Client Site)
- Medical, Dental, and Vision Insurance
- Employer-paid long-term disability and short-term disability
- A $50,000 team member only life insurance & ADD policy
- 401k plan with employer contributions
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 Engineering, CQV, and Quality & Compliance.
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 value our employees, and beyond the great pay and benefits we offer, we care most about offering career opportunity and growth. 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 currently unable to sponsor.
Accessibility: If you need an accommodation as part of the employment process please contact Human Resources at
Equal Opportunity Employer, including disabled and veterans.
If you want to view the Pay Transparency Policy Statement, please click the link: English
GAMP, SDLC, LIMS, Labvantage, Labware, Empower, CFR, data integrity, automation, traceability, deviations, requirements, qualification, UAT, user acceptance test, SOPs, deviations, VMP, HP ALM, KNEAT, Agilent, Waterfall
- Pay Type Salary
- 2500 Gateway Centre Blvd, Morrisville, NC 27560, USA