Senior CQV Engineer / Senior Validation Engineer
A leading consultancy in the life sciences sector is seeking a Senior Commissioning, Qualification, and Validation (CQV) Engineer to support validation and compliance efforts for pharmaceutical manufacturing systems. This role is ideal for professionals with a strong background in process equipment validation and a passion for quality and operational excellence.
Position Summary
The Senior CQV Engineer will be responsible for designing and executing validation strategies, conducting risk assessments, and supporting the implementation of automated and process systems. This role requires a deep understanding of GMP environments, validation documentation, and the ability to work independently while mentoring junior team members.
Key Responsibilities
- Develop and execute validation plans and protocols for equipment, systems, and software.
- Conduct impact and risk assessments, identifying direct, indirect, and non-impact systems within complex processes.
- Maintain detailed records of qualification, validation, and change control activities to support audit readiness.
- Design and perform engineering studies to define and verify critical process parameters.
- Author, review, and execute commissioning and qualification documentation (URS, IQ, OQ, PQ).
- Perform user interface testing, software verification, and alarm testing on automated systems.
- Analyze test results and recommend design or process improvements.
- Ensure adherence to project timelines and deliverables.
- Collaborate with cross-functional teams to ensure alignment with project goals and regulatory expectations.
Candidate Requirements
- Location: Must be available to work on-site in Indianapolis, IN.
- Education: Bachelor's degree in engineering or a related technical field.
- Experience: 4+ years in a GMP-regulated environment with demonstrated experience in CQV for process equipment.
- Skills:
- Strong understanding of validation lifecycle documents and regulatory compliance.
- Ability to lead and mentor junior team members.
- Excellent written and verbal communication skills.
- Proficiency in Microsoft Word (technical documentation), Excel, and PowerPoint.
- Strong organizational skills and attention to detail.
- Ability to work independently and manage multiple priorities.
- Experience with capital equipment implementation and process design is a plus.
- Familiarity with Good Documentation Practices (GDP) and GMP standards.
Work Authorization: Applicants must have the legal right to work in the United States without the need for current or future sponsorship.
Why Join This Team?
- Be part of a collaborative and mission-driven organization focused on improving healthcare outcomes.
- Work on high-impact projects in a fast-paced, innovation-driven environment.
- Access to professional development, mentorship, and growth opportunities.
- Inclusive culture that values integrity, learning, and teamwork.
- Participate in team-building events and employee recognition programs.
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.