Sequence is a leader in providing quality and compliance services to the Pharmaceutical, Biotech, and Medical Device industries. United with our clients, we strive to provide services that result in products of the highest quality. Through our knowledge, experience, and integrity we offer a level of service that is unsurpassed industry wide. We Specialize in Providing Excellence in Automation & Control Systems Validation, Information Systems Validation, Software Configuration/Builds & Administration, Training, Equipment & Utility Validation, Laboratory Instrument Qualification, Project Leadership, Auditing, SOP Development, Remediation, and much more.

We are currently seeking an MES Validation Engineer (Senior Consultant level) for the Raleigh-Durham area. Candidates will need experience in Management Execution Systems (MES) related to PAS-X in addition, but not limited to, Computer Systems Validation (CSV), the Software Development Life-Cycle (SDLC), change controls, and protocol generation. Experience working with or validating lab instruments, along with using systems such as Empower, Trackwise, Serialization systems, Infrastructure, Networks, Server/Hardware Qualification, and Cloud Computing is a plus. A willingness to travel is preferred.

Essential Functions and Responsibilities

  • Daily management of project activities and deliverables
  • Utilizing knowledge of PAS-X Management Execution 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
  • Batch Records, Test Execution and Deviation Management
  • Planning and scheduling of System Development Life Cycle (SDLC) 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 clients business and offer impactful solutions fit 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

  • 3-5+ years of applicable work experience in the pharmaceutical or biotechnology industry
  • 5+ years SDLC, PAS-X, and MES
  • 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 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. 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.

 

Equal Opportunity Employer, including disabled and veterans.

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