We’re currently interviewing for a full-time only Mid-Senior Level LIMS Developer and Business Analyst with experience in LIMS and Computer Systems Validation documentation to act as a hands-on Consultant for our Southeast Software Data Management Services (SDMS) Business Unit. In this role, you’ll be responsible for LIMS implementation and validation projects as they relate to biomanufacturing, biotech, and other regulated industries (21 CFR parts 11, 210, and 211).
This position is intended for those who embody Sequence’s core values of selfless Attitude, Aptitude for continued learning, and unstoppable Initiative.
Do you love to travel and explore new places? This position will primarily be based out of our Morrisville, North Carolina office but may require a minimal amount of travel for specific projects (roughly 25%). The majority of projects are within the pharmaceutical industry. If you have the ability to travel out-of-state you’ll be given top priority for this role!
In this role you’ll be held responsible for the day-to-day management of specific project activities and deliverables, including, but not limited to:
Essential Functions and Responsibilities:
- Work collaboratively with Quality, Manufacturing, Vendor and IT at all levels to meet project deliverables and timelines
- Interact with the Laboratory operations group to support LIMS implementation and ongoing support for new module implementations and/or installation of new capabilities
- Work cross functionally to integrate LIMS in a cGMP environment
- Development of LIMS functionality
- Partner with IT and laboratory organizations, support users by responding to change requests and training needs
- Comply with Software Development Lifecycle (SDLC) and company’s Computer Systems Validation (CSV) process and procedures
- Work collaboratively to manage, analyze and maintain complex master data and custom configuration in LIMS system
- Actively participate in all phases of application implementation, including ownership of key deliverables such as
- User Requirements Specifications
- Function Specification
- Design Specifications
- User acceptance testing
- Validation documentation
- Deployment support
- Assist in developing Standard Operating Procedures (SOPs) for global and local Laboratory Information Management (LIMS) Systems
- Identify and recommend areas of process improvement
- Perform knowledge transfer and provide ongoing leadership, to support project go-live and beyond, operations and support activities
At a minimum your skills include:
- 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
- LIMS development and implementation experience (Labware, LabVantage, Empower)
- 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
It would be fantastic if you also had:
- 5+ years’ experience analyzing business requirements and supporting information systems projects
- Experience in areas such as sampling, pharmaceutical quality control lab, laboratory data and reports (C of C, C of A), data management, change control, GLP/GMP and compliance
- Experience in a manufacturing environment is preferred. Experience with supporting a multi-site enterprise system with master data (LIMS, MES, PLM) preferred
- Comfortable in a fast-paced growing company with minimal direction and able to adjust workload based upon changing priorities
- Computer Systems Validation and GxP processes strongly preferred
Here are some of the benefits we offer:
- Competitive Pay as a Full Time Employee
- A Three-Week Training Program with on-going training thereafter
- Generous PTO/ Time off
- Bonus Plan
- Reimbursable Expenses (Phone, Internet, and Mileage to Client Site)
- 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
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 Engineering, CQV, and Quality & Compliance.
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.
We value our employees, and beyond the great pay and benefits we offer, we care most about offering career opportunity and growth. 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.
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- Pay Type Salary
- 2500 Gateway Centre Blvd, Morrisville, NC 27560, USA