Sequence Inc. is a total quality solutions provider to the Pharmaceutical, Biotech, and Medical Device 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. We specialize in providing excellence in Automation & Control Systems Validation, Information Systems Validation, Software Configuration/Builds & Administration, Training, Equipment & Utility Qualification and Validation, Laboratory Instrument Qualification, Project Leadership, Auditing, SOP Development, Remediation, and much more.

At Sequence Inc., our employees embody core values that strengthen our culture and guide our overall success. The ability to maintain a selfless, humble 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 a Laboratory Validation Engineer (Consultant level) with a background in microbiology for the Raleigh-Durham area. Candidates will need experience in Good Laboratory Practices (GLP), the validation life-cycle, and authoring and executing protocols for microbiology lab instrumentation. Method validation experience is a plus. A willingness to travel both national and international at a minimum of 75% (average 1 to 3 weeks at a time) is preferred.

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
  • Maintaining and developing the relationship between clients and Sequence, Inc.
  • Communicating any potential new business leads to the appropriate business unit representative and Sequence
    business development.
  • Addressing new projects or other events within their business unit or clients that may affect our business
    relationship either positively or negatively.
  • Providing project management/oversight to ongoing client projects within their respective division.

Minimum Requirements

  • Advanced understanding of the Validation Lifecycle
  • Advanced Understanding of Regulatory Compliance and Quality Assurance within regulated industries
  • Advanced understanding of business processes as applicable to area of expertise
  • Experienced in developing and managing relationships with clients in a consulting capacity
  • Ability to apply knowledge in training of other consultants
  • Advanced knowledge of GxP, GAMP, CFR’s as they apply across multiple regulated industries
  • Experienced in applying SOPs, work instructions and regulatory requirements to the Systems Validation and Quality project management

Preferred Experience

  • BS in Science/Microbiology (or higher) with GMP experience in the Pharma industry
  • 5+ years experience in regulated industries with at least 3 years in Quality and Compliance related roles
  • 1+ years work experience in a consulting capacity

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
  • Employer-paid long-term disability and short-term disability
  • 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 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.

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Equal Opportunity Employer, including disabled and veterans.