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 a Laboratory Informatics Technical Lead (Consultant level) for our Software Management Services Division. Persons will be responsible for day-to-day management of their specific project activities and deliverables, including, but not limited to:
Essential Functions and Responsibilities:
• Daily management of client project activities and deliverables
• Serve as the internal Subject Matter Expert (SME) for identified lab informatics systems
• Apply technical expertise to assist client stakeholders with analyzing user needs and gathering user requirements
• Implement and configure LIMS, ELN and CDS systems and develop custom components based on client requirements
• Integrate laboratory instruments and other (scientific and non-scientific) applications with lab informatics systems
• Develop dynamic reports based on client requirements
• Develop and deliver formal and informal training for clients and internal resources
• Validation documentation creation and development including GxP Assessments, Validation Plans, Risk Assessments, Requirements/Design/Functional Specifications, IQ/MQ/OQ/PQ Protocols, Reports, Traceability Matrix, and Standard Operating Procedures
Minimum Requirements:
• BS or MS in a life science, computer science, engineering or equivalent experience
• 5+ years of applicable work experience within a GxP regulated setting
• Exceptional communication and organizational skills
• Ability to work independently and make decisions within defined areas of responsibility
• Ability to develop and manage client relationships while identifying new opportunities
• Understanding of business processes as applicable to lab informatics systems
• Understanding of System Development Life Cycle (SDLC) methodologies
• Understanding of Computer System Validation Lifecycle (GAMP 5)
• Understanding of GxP, GAMP, CFR’s as they relate to computer system validation
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 you 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.
