Commissioning & Qualification (CQV) Engineering Consultant

3 days ago

Framingham MA United States Sequence Inc. Full time

We are currently interviewing candidates to join Sequence, Inc. as CQV Consultants within our 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.

This position is intended for those who embody Sequence’s core values of selfless Attitude, Aptitude for continued learning, and unstoppable Initiative.

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

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:

  • Bachelor's Degree in Engineering
  • 0-5 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

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

About Us:

Sequence Inc. is a total quality solutions provider to Pharmaceutical, Biotech, 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 (full-lifecycle). We specialize in providing excellence in Engineering, CQV, and Quality & Compliance.

Our employees embody core values that strengthen our culture and guide our overall success. The ability to maintain a selfless attitude creates a respectful environment where ideas are shared and valued. Our teams possess the technical proficiency to do the work and the Aptitude to continue learning, growing, and stretching their potential. Our unstoppable Initiative and willingness to get things done using new ideas grows our capabilities and drives our future achievements.

We value our employees, and beyond the great pay and benefits we offer, we care most about offering 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 without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.

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.

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