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Commissioning & Qualification Engineering Consultant

We are currently interviewing candidates to join Sequence, Inc. as CQV Consultants within our Northeast & Southeast Operations with most projects focused in the pharmaceutical/biotechnology industries. In this role, you will be responsible for a range of projects related to the commissioning & qualification of automated manufacturing systems including laboratory instrumentationmanufacturing equipment, and stand-alone computerized systems. In addition, you will have the opportunity to be immersed in Pharma 4.0™ transformations and implementations. 
Do you love to travel and explore new places? This position may require travel for specific projects with the opportunity to grow and work locally, primarily within the Greater Boston Area. Most projects are within the pharmaceutical industry. If you are willing to travel out-of-state and/or temporarily relocate you will be given top priority for this role! 
In this role you will be held responsible for the day-to-day management of specific project deliverables, including, but not limited to: 

Position Accountabilities and Responsibilities: 
  • Creation and modification of design documentation including user requirements specifications (URS), functional requirement specifications (FRS), and detailed design documentation
  • Creation and participation in system classification, system risk assessment, Data Integrity assessments, and vendor assessments
  • Participate in and document design review and design qualification activities
  • Commissioning and Qualification (C&Q) planning and associated documentation such as Validation Master Plans, Validation Project Plans, Commissioning and Qualification Plans, etc.
  • Commissioning & Qualification testing and documentation including:
  • P&ID walk-downs to determine As-Built drawings represent the actual system and identify issues with instrumentation and/or equipment
  • Participate in meetings as the engineering representative for assigned projects involving project planning, scope development, design, construction, startup, qualification, validation, and administration
  • Perform Receipt and Installation verification for control system hardware and various equipment supporting utilities and process operations
  • Draft startup and shakedown documentation to assist process engineers with identification of mechanical, automation, and/or process issues prior to commissioning
  • Identify discrepancies, conduct investigations to determine root cause, implement change, and draft testing to demonstrate corrective action implementation reflects intended functionality
  • Draft commissioning and qualification protocols to sufficiently demonstrate the process is designed and fit for the intended use
  • Execute performance qualification to verify that facilities, utilities, equipment, and associated computer systems once connected can perform effectively and reproducibly utilizing approved process methods and specifications
  • Execute acceptance and release activities including summary reports and traceability matrices
  • Support on-going system requalification and continuous improvement activities governed by change management processes
At a Minimum, Your Skills Should Include:
  • Must have a proficient understanding of life cycle documentation: User Requirement Specification (URS), Functional Requirement Specification (FRS), and Detailed Design Specification (DDS)
  • Strong technical writing skills and proficient utilization of MS Word, Excel, Visio, PowerPoint, and Project
  • Excellent communication and organizational skills
  • Ability to develop and manage client relationships
  • A willingness to update and maintain knowledge by participating in educational opportunities and maintaining personal networks
It would be fantastic if you also had:
  • Knowledge and utilization of regulatory compliance standards and quality assurance within regulated industries
  • Understanding of business and manufacturing processes as applicable to manufacturing sciences
  • Understanding of GxP, GAMP, CFR’s (Part 11, 210, and 211)
  • Understanding of how to apply SOPs, work instructions, and regulatory requirements
  • Technical background encompassing process and automation with the ability to identify issues regarding process and/or automation
Here are Some of the Benefits We Offer:  
  • Competitive Pay as a Full Time Employee 
  • An 8-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 

Start Date: January 2024