Sequence Inc Computer System Validation Professional in Boston, Massachusetts
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 have specialized experience integrating and validating many automation and software solutions widely used in regulated industries, allowing us to offer related support and administration services for comprehensive compliance solutions.
We are currently looking for a Computer System Validation professional (Consultant level) for the Raleigh-Durham area. Candidates will need experience with a range of computerized systems including but not limited to: SAP, Documentum, MasterControl, LIMS, Empower, Maximo, Trackwise, Serialization systems, Infrastructure, Networks, Server/Hardware Qualification, Cloud Computing.
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
Ability to develop and manage client relationships while identifying new opportunities
Knowledge and utilization of regulatory compliance standards and quality assurance within regulated industries, with the ability to understand client’s business and offer impactful solutions fit to their needs
Understanding of the Computer Validation Life Cycle
Knowledge of GxP, GAMP, CFR’s (Part 11)
Exceptional communication and organizational skills
Willingness to update and maintain knowledge by participating in educational opportunities and maintaining personal networks
3+ years of applicable work experience in the pharmaceutical or biotechnology industry
Understanding of the Validation Lifecycle (GAMP 5)
Understanding of business processes as applicable to computerized systems
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 of computerized systems
Understanding of Agile methodology
Understanding of Data Integrity concepts
Understanding of Cloud Computing
Experience with electronic testing tools such as HP ALM
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:
Medical, dental, and vision Insurance
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 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.