Formed in 2002 out of a need for high-caliber consultants within the life sciences industry. Sequence, Inc. is well-known in regulated industries as a validation and engineering services provider, specializing in quality and compliance services for software, IT infrastructure, laboratory instruments, analytical methods, equipment, automation, processes, cleaning and utilities, as well as process optimization, laboratory software support, remediation, regulatory compliance services, system/facility startup and much more. All of our work is done in-house with oversight from a management team that cut its teeth in regulatory compliance.
We are currently seeking multiple Laboratory Instrument Validation Specialists (Senior Consultant level) for our Validation and Compliance Division. Candidates with the ability to travel out-of-state will be given preference on these roles. 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:
- Validation documentation creation and development including GxP Assessments, Change Control, Validation Plans, Risk Assessments, Requirements/Design/Functional Specifications, Supplemental IQ/OQ/PQ Protocols, Traceability Matrices, Summary/Final Reports, and Standard Operating Procedures
- Managing vendor installations and vendor validation documentation
- Providing Gap Analysis on existing laboratory assets
- Routing of documentation
- Test execution and deviation management
- Planning and scheduling of validation and validation life-cycle deliverables.
- Providing regulatory guidance regarding compliance with intended specifications, policies affecting final product integrity, and regulations (GxP, ICH, etc.) to the client
- Provide site specific team management for junior level resources (mentoring/guidance/peer review)
- Performing periodic assessments of previously validated assets.
- BS or MS in a life science, engineering or equivalent work experience
- Minimum of 5 years working within a GxP regulated setting (Laboratory, Quality, Manufacturing, IT) for the senior role, 2 years for the staff-level role
- Familiarity with a variety of Laboratory Instrumentation/Equipment – Chemistry/Microbiology/Environmental Monitoring/Controlled Temperature Units
- Troubleshooting various vendor instrument software applications
- Exposure to lab operations and scientific processes associated with various area (Chemistry, Micro, Bio, EM etc.)
- Ability to work independently and as a group on multiple projects at once
- Work as a liaison between IT and Laboratory Departmental Management
- Ability to adapt and work well with others specifically Quality Assurance with review and approval of documentation
- General knowledge of basic lab safety principles
- Understanding of the Validation Life-cycle (GAMP 5)
- Understanding of business processes as applicable to the laboratory
- Understanding of GxP, GAMP, CFR’s as they relate to the laboratory validation
- Understanding of applying SOPs, work instructions and regulatory requirements to the Systems 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. We are unable to sponsor at this time.