We are currently considering Validation Professionals at various levels of experience on a full-time only basis to act as hands-on Consultants for our Southeast Quality and Compliance Service Divisions (IT Quality, Laboratory, and Manufacturing) to be responsible for projects in commissioning/qualification/validation as they relate to the biomanufacturing, biotech, and other regulated industries (21 CFR parts 11, 210, and 211). This position may require travel for specific projects with opportunity to grow and work locally, primarily within the greater Raleigh-Durham area (NC). The majority of projects are within the pharmaceutical industry, with potential for medical devices, general manufacturing, and agriculture. Candidates with the ability to travel out-of-state and/or temporarily relocate will be given top priority for this role. Persons will be responsible for the day-to-day management of their specific project activities and deliverables, including, but not limited to:
Essential Functions and Responsibilities:
Attending to clients as a full support solution to quality and compliance
Daily management of project activities and deliverables
Hands-on full-lifecycle commissioning, qualification (IQ/OQ/PQ), and validation in one or more of the following environments: IT Quality, QC Lab, Microbiology Lab, Biomanufacturing
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 travel long-term or temporarily relocate to project sites
Ability to develop and manage strong relationships
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
Understanding of the full IQ/OQ/PQ and Validation Life Cycle (GAMP5)
Knowledge of GxP, GAMP, CFR’s (Part 11, 210, and 211)
Exceptional communication and organizational skills
Willingness to update and maintain knowledge by participating in educational opportunities and maintaining personal networks
A bachelor’s degree from an ABET accredited institution in a life sciences or related discipline, or equivalent experience as it relates to the job description
Consultant I: 1-3 years of applicable work experience in the pharmaceutical or biotechnology industry
Consultant II: 4-7 years of applicable work experience in the pharmaceutical or biotechnology industry
Senior Consultant: 8+ years of applicable work experience in the pharmaceutical or biotechnology industry
Principal Consultant: 10+ years of applicable work experience in the pharmaceutical or biotechnology industry
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 one or more of the following environments as they relate to validation: IT Quality Systems, Laboratory, Manufacturing
Our consultants must be knowledgeable and willing to go the extra mile in the service of a client, your success is our success. Here are some of the Benefits we offer:
A Three-Week Training Program
Medical, Dental, and Vision Insurance
Employer-paid long-term disability and short-term disability
Maternity and Paternity
A $50,000 team member only life insurance & ADD policy
401k plan with employer contributions
Generous PTO/ Time off
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 career 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.
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
Equal Opportunity Employer, including disabled and veterans.
If you want to view the EEO is the Law Supplement poster, please choose your language: English – Spanish – Chinese
If you want to view the Pay Transparency Policy Statement, please click the link: English
Additional Salary Information: Competitive Salary, with compensation for overtime, a profit-sharing program, travel incentive & reimbursement options.
Internal Number: 0001
About Sequence, Inc.
Headquartered in North Carolina and founded in 2002 by CEO, Mike Putnam, 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 Validation, Quality and Compliance, Data Architecture & Analytics, Laboratory Informatics, Cold Chain & Facility Monitoring, Engineering, Integration & Automation, and Construction Management.
At Sequence Inc., 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.