Senior CQV Engineer
Must be a US citizen or a green card holder
Senior CQV Engineer
Overview
A leading engineering, validation, and life sciences consulting organization is seeking a Senior CQV Engineer to support the commissioning, qualification, and validation of manufacturing equipment and systems within regulated production environments. This role is responsible for providing technical engineering expertise throughout equipment implementation, startup, testing, and qualification activities while ensuring compliance with applicable quality and regulatory requirements.
Key Responsibilities
- Provide engineering and CQV support for the implementation, modification, commissioning, and qualification of manufacturing equipment and systems.
- Develop a thorough understanding of equipment design, functionality, controls, operating principles, and intended use.
- Serve as a technical resource throughout equipment design, installation, commissioning, startup, and qualification activities.
- Review engineering drawings and technical documentation, including:
- P&IDs
- Equipment specifications
- Datasheets
- Electrical drawings
- Vendor documentation
- Participate in design reviews and provide input on operability, maintainability, functionality, and qualification requirements.
- Coordinate activities with engineering, automation, manufacturing, quality, contractors, vendors, and other project stakeholders.
- Execute and support equipment startup, commissioning, troubleshooting, and qualification activities.
- Identify and resolve equipment and system issues in collaboration with project teams and vendors.
- Support Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), commissioning, and qualification efforts.
- Provide hands-on field support during installation, startup, testing, and qualification activities.
- Support investigation and resolution of technical issues encountered during commissioning and qualification.
Documentation Responsibilities
Author, review, and maintain CQV and engineering documentation, including:
User Requirements Specifications (URS)
Commissioning Protocols
Installation Qualification (IQ) Protocols and Reports
Operational Qualification (OQ) Protocols and Reports
Performance Qualification (PQ) Protocols and Reports
Risk Assessments
Traceability Matrices
Engineering Studies
Deviations and Discrepancy Reports
Turnover and Closeout Documentation
Ensure all commissioning and qualification activities are documented and executed in compliance with project requirements, quality standards, and cGMP expectations.
Track assigned deliverables against project schedules and communicate risks, issues, and progress to project leadership.
Qualifications
- Bachelor's degree in Engineering, Life Sciences, or a related technical discipline, or equivalent industry experience.
- 5+ years of experience supporting commissioning, qualification, validation, engineering, or equipment implementation projects within regulated manufacturing environments.
- Strong understanding of manufacturing equipment and process systems, including design, installation, operation, maintenance, and testing.
- Experience supporting equipment installation, startup, commissioning, qualification, or project engineering activities.
- Experience collaborating with vendors, engineering teams, manufacturing personnel, and quality organizations.
- Working knowledge of the fullCQVlifecycle, including:
- FAT
- SAT
- Commissioning
- IQ
- OQ
- PQ
- Ability to read and interpret engineering drawings, P&IDs, equipment specifications, and technical documentation.
- Strong technical writing skills with experience generating validation and qualification documentation.
- Strong troubleshooting, root cause investigation, and problem-solving abilities.
- Understanding of cGMP requirements and Good Documentation Practices (GDP).
- Excellent communication, organization, and project coordination skills.
- Ability to work independently and effectively within multidisciplinary teams.
Preferred Industry Experience
Candidates with experience in the following environments are strongly encouraged to apply:
- Pharmaceuticals
- Biotechnology
- Medical Devices
- Cell & Gene Therapy
- Consumer Healthcare
- Other FDA-regulated manufacturing industries
What You'll Gain
- Exposure to large-scale capital projects and advanced manufacturing facilities.
- Opportunities to lead CQV efforts from design through operational readiness.
- Collaborative work alongside engineering, automation, manufacturing, and quality teams.
- Professional growth within a highly regulated and technically challenging environment.
- Competitive compensation and comprehensive benefits package based on experience and qualifications.
FAQs
Congratulations, we understand that taking the time to apply is a big step. When you apply, your details go directly to the consultant who is sourcing talent. Due to demand, we may not get back to all applicants that have applied. However, we always keep your resume and details on file so when we see similar roles or see skillsets that drive growth in organizations, we will always reach out to discuss opportunities.
Yes. Even if this role isn’t a perfect match, applying allows us to understand your expertise and ambitions, ensuring you're on our radar for the right opportunity when it arises.
We also work in several ways, firstly we advertise our roles available on our site, however, often due to confidentiality we may not post all. We also work with clients who are more focused on skills and understanding what is required to future-proof their business.
That's why we recommend registering your resume so you can be considered for roles that have yet to be created.
Yes, we help with resume and interview preparation. From customized support on how to optimize your resume to interview preparation and compensation negotiations, we advocate for you throughout your next career move.