Formed in 2002 out of a need for high-caliber consultants within the life sciences industry. Sequence, Inc. is well-known in regulated industries as a validation and engineering services provider, specializing in quality and compliance services for software, IT infrastructure, laboratory instruments, analytical methods, equipment, automation, processes, cleaning and utilities, as well as process optimization, laboratory software support, remediation, regulatory compliance services, system/facility startup and much more. All of our work is done in-house with oversight from a management team that cut its teeth in regulatory compliance.
We are currently looking for a Computer System Validation professional (Consultant level) for the Raleigh area. Candidates will need experience with a range of computerized systems including but not limited to: SAP, Documentum, MasterControl, LIMS, Empower, Maximo, Trackwise, Serialization systems, Infrastructure, Networks, Server/Hardware Qualification, Cloud Computing.
Essential Functions and Responsibilities
- Daily management of project activities and deliverables
- 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
- Ability to develop and manage client relationships while identifying new opportunities
- Knowledge and utilization of regulatory compliance standards and quality assurance within regulated industries, with the ability to understand client’s business and offer impactful solutions fit to their needs
- Understanding of the Computer Validation Life Cycle
- Knowledge of GxP, GAMP, CFR’s (Part 11)
- Exceptional communication and organizational skills
- Willingness to update and maintain knowledge by participating in educational opportunities and maintaining personal networks
- 3+ years of applicable work experience in the pharmaceutical or biotechnology industry
- Understanding of the Validation Lifecycle (GAMP 5)
- Understanding of business processes as applicable to computerized systems
- 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 of computerized systems
- Understanding of Agile methodology
- Understanding of Data Integrity concepts
- Understanding of Cloud Computing
- Experience with electronic testing tools such as HP ALM
Our consultants must be knowledgeable and willing to go the extra mile in service of a client, your success is our success. Here are some of the Benefits we offer:
- Competitive Pay
- Medical, Dental, and Vision Insurance
- 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 care most about offering 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 be an Equal Opportunity Employer, M/V/D/F. You will be considered for this position based upon your experience, without regard to race, color, religion, sex, national origin, age, sexual orientation, ancestry; marital, disabled or veteran status. Applicants for employment in the US must have work authorization that does not now or in the future require sponsorship of a visa for employment authorization in the United States and with Sequence.
Candidates who are currently employed by a client of Sequence or an affiliated Sequence business may not be eligible for consideration.