Sequence Inc. ยท 1 day ago
Commissioning & Qualification (CQV) Engineering Consultant
Triangle Area
Full-time
Hybrid
New Grad, Entry Level
$70K/yr - $80K/yr
0+ years expSequence Inc. is an engineering consulting firm specializing in ensuring that facilities and manufacturing processes meet end user requirements. The CQV Engineering Consultant will be responsible for managing project deliverables related to the commissioning and qualification of automated manufacturing systems, including creating design documentation and executing qualification testing.
BiotechnologyHealth CarePharmaceutical
No H1B
Hiring Manager
Ileana Utke
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
Occasionally work alongside the training team to help onboard and train new employees as well as assist with client training as needed
Perform other related duties as assigned
Qualification
Required
Bachelor's Degree in Engineering
0-3 years of relevant experience
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
Preferred
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
Benefits
Competitive Pay as a Full Time Employee
A 4 week Training Program with on-going training thereafter
Generous PTO/ Time off
Bonus Plan
Reimbursable Expenses
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
Company
Sequence Inc.
Sequence is a pharmaceutical company that offers lab systems validation and compliance services.
201-500 employees
Funding
Current Stage
Growth StageLeadership Team
Mike Putnam
Visionary & CEO
Andrew Wilding
Integrator & CFO
Company data provided by crunchbase