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 commissioning, 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 have specialized experience integrating and validating many automation and software solutions widely used in regulated industries, allowing us to offer related support and administration services for comprehensive compliance solutions.

We are currently looking for a Computer System Validation professional (Consultant level) for the Winston-Salem area. Candidates will need experience with a range of computerized systems including but not limited to: Document Management Systems, Lab Information Systems, Maintenance and Calibration Management Systems, project management tools, etc. Experience with systems such as SAP, Documentum, MasterControl, LIMS, Empower, Maximo, Trackwise, Serialization systems, Infrastructure, Networks, Server/Hardware Qualification, Cloud Computing is preferred. While this position is primarily based in Winston-Salem, overnight travel should be anticipated in the future (potentially up to 75%).

Essential Functions and Responsibilities

  • Daily management of project activities and deliverables
  • Providing top-level 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

Minimum Requirements

  • 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

Preferred Experience

  • 3+ years of applicable work experience in the pharmaceutical or biotechnology industry
  • Complete understanding of the Validation Lifecycle (GAMP 5)
  • Command of validation lifecycle approach (URS, FRS, FAT/SAT, Commissioning Protocols, ect.)
  • Expertise of Quality by Design (QbD) principles and approach
  • Capability to read and redline equipment P&ID and facility layout drawings
  • 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 offer, 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.  We are unable to sponsor at this time.

 

Accessibility: If you need an accommodation as part of the employment process please contact Human Resources at
Email: cburchell@sequenceqcs.com

Equal Opportunity Employer, including disabled and veterans.

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