Commissioning & Qualification (CQV) Engineering Consultant

Commissioning & Qualification (CQV) Engineering Consultant - Southeast

1400 Perimeter Park Dr, Morrisville, NC 27560, USA Req #104

Tuesday, September 3, 2024

Thank you for your interest in Sequence! We aim to contact as many applicants as possible, but only those selected for an interview will be contacted.

We are currently interviewing candidates to join Sequence, Inc. as CQV Consultants within our Southeast Operations, focusing on the pharmaceutical/biotechnology industries. In this role, you will be responsible for projects related to the commissioning & qualification of automated manufacturing systems including laboratory instrumentation, manufacturing equipment, and stand-alone computerized systems. You will also have the opportunity to engage in Pharma 4.0 transformations and implementations.

Do you love to travel and explore new places? Depending on project demands, you may be required to temporarily relocate to project sites, both domestically and internationally, for extended durations. You may also engage in occasional travel for client meetings or to complete project deliverables, typically ranging from 10% to 30% of your working time. The extent of travel will be project-specific and communicated in advance.

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 ensure 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 identifying 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 demonstrate the process is designed and fit for the intended use
• Execute performance qualification to verify that facilities, utilities, equipment, and associated computer systems can perform effectively and reproducibly utilizing approved process methods and specifications
• Execute acceptance and release activities including summary reports and traceability matrices
• Support ongoing system requalification and continuous improvement activities governed by change management processes
• Occasionally work alongside the training team to help onboard and train new employees and assist with client training as needed
• Perform other related duties as assigned

Minimum Skills Required:

• Bachelor's Degree in Engineering
• 0-3 years of relevant experience
• 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 Skills:

• 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 We Offer:

• Competitive Pay as a Full Time Employee
• An 8-week Training Program with ongoing 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

About Us:

Sequence Inc. is a total quality solutions provider to Pharmaceutical, Biotech, and Life-Science industries. United with our clients, we strive to provide services that result in deliverables of the highest quality. Through our knowledge, experience, and integrity, we offer a level of service that is unsurpassed industry-wide. We specialize in providing excellence in Engineering, CQV, and Quality & Compliance.

We value our employees and offer career opportunity and growth. We are a rapidly growing consulting firm and would love to discuss the prospect of you joining our team. Sequence Inc. is proud to provide Equal Employment Opportunities, EOE/M/F/D/V, to all employees and applicants for employment and prohibits discrimination and harassment of any type.

This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.

Candidates who are currently employed by a client of Sequence or an affiliated Sequence business may not be eligible for consideration.

We are currently unable to sponsor.

Accessibility: If you need an accommodation as part of the employment process please contact Human Resources at Email: wramey@sequenceqcs.com

Equal Opportunity Employer, including disabled and veterans.

If you want to view the EEO is the Law Supplement poster, please choose your language: English – Spanish – Chinese

If you want to view the Pay Transparency Policy Statement, please click the link: English