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 an Automation Validation Engineer (Consultant level) for our Validation and Compliance Division.  Candidates will need experience with a range of automation systems including but not limited to; SCADA systems, PLCs, Distributed Process Control Systems (DeltaV, etc.).  Experience with Building Automation Systems (BAS) and Manufacturing Execution Systems (MES) a plus.

Essential Functions and Responsibilities:

• Providing Regulatory Guidance regarding compliance with intended specifications, policies affecting final product integrity, and regulations (GxP, ICH, etc.)
• Validation documentation creation and development including GxP Assessments, Validation Plans, Risk Assessments, Requirements/Design/Functional Specifications, IQ/OQ/PQ Protocols, Reports, and Standard Operating Procedures
• Managing Vendor Installations and Vendor Validation Documentation
• Test Execution, Troubleshooting, and Deviation Management
• Planning and scheduling of validation and Validation Lifecycle deliverables
• Daily management of project activities and deliverables

Minimum Requirements:

• 2+ years of applicable work experience in the pharmaceutical or biotechnology industry
• Knowledge of ASTM E2500 and risk based testing methods with regard to control system commissioning and qualification
• Knowledge of ANSI/ISA-88 (S88) batch control standard
• 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 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 of automation systems
• Strong Biotechnology and Pharmaceutical process knowledge
• Exceptional communication and organizational skills
• Willingness to update and maintain knowledge by participating in educational opportunities and maintaining personal networks

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.