Commissioning & Qualification (C&Q) Engineer I / II
The Commissioning & Qualification (C&Q) Engineer role at Confidential Client involves supporting pharmaceutical manufacturing projects through equipment startup, commissioning, qualification, and validation activities within GMP-regulated environments. The position requires executing and leading commissioning protocols, managing documentation, troubleshooting, and collaborating with project teams to ensure successful project delivery and compliance. Opportunities exist for both entry-level and experienced engineers to contribute to large-scale capital projects and gain exposure to advanced pharmaceutical manufacturing systems.
About Careertakes
👉 Important disclosure: Careertakes is a third-party recruiting platform supporting this hiring process. If selected, you will be employed directly by our client, a Confidential Client in the pharmaceutical manufacturing industry.
Applicants for this role may also receive access to additional matched opportunities through the Careertakes platform.
What You’ll Do
This role supports commissioning, qualification, validation, and startup activities for large-scale pharmaceutical manufacturing projects in the Indianapolis, IN area. Candidates will be considered at either C&Q Engineer I (entry) or C&Q Engineer II (experienced) levels depending on background.
- Execute commissioning and qualification protocols for process equipment, utilities, facilities, and support systems.
- Perform field testing, system walkdowns, startup support, and troubleshooting activities.
- Support FATs (Factory Acceptance Tests) and SATs (Site Acceptance Tests) as required.
- Develop, review, and execute commissioning/qualification documentation and reports.
- Ensure compliance with GMP, Good Documentation Practices, and client procedures.
- Support deviation investigations, corrective actions, and change management.
- Collaborate with project managers, engineering teams, contractors, vendors, and client personnel to meet project milestones.
- Maintain organized, audit-ready project documentation.
Responsibilities (by level)
C&Q Engineer I (Entry-level)
- Execute qualification protocols under supervision and assist with commissioning/startup tasks.
- Support data collection, documentation, and field troubleshooting.
- Learn GMP requirements, validation methodologies, and project processes.
- Support project teams to meet schedule and quality objectives.
C&Q Engineer II (Experienced)
- Independently develop and execute commissioning and qualification protocols.
- Lead system walkdowns, startup activities, and troubleshooting.
- Manage assigned systems from construction completion through qualification and turnover.
- Author qualification reports, investigations, and technical documentation.
- Interface with clients, contractors, and vendors; mentor junior engineers.
- Lead deviation resolution and technical investigations; drive deliverables to completion.
Minimum Qualifications
- Bachelor’s degree in Engineering, Engineering Technology, or related technical discipline.
- C&Q Engineer I: 0–2 years relevant experience.
- C&Q Engineer II: 2–5+ years relevant experience in commissioning, qualification, validation, pharmaceutical manufacturing, or regulated industries.
- Strong written and verbal communication skills.
- Ability to interpret P&IDs, process flow diagrams, equipment drawings, and technical specifications (especially for C&Q II).
- Comfortable working in construction and manufacturing environments and following safety procedures.
- Ability to work both independently and collaboratively on project teams.
Preferred Qualifications
- Direct C&Q/CQV experience supporting pharmaceutical, biotechnology, or life sciences projects.
- Experience with clean utilities, process equipment, facility systems, or automation platforms.
- Familiarity with DeltaV, BAS, SCADA, or other control systems.
- Internship, co-op, or prior project experience in pharmaceutical or regulated manufacturing environments.
- Experience supporting facility startup and capital project execution.
Why Join Our Client (Confidential Client)
- Work on some of the largest pharmaceutical manufacturing projects in the industry.
- Collaborate with experienced engineering and validation professionals.
- Exposure to commissioning, qualification, validation, automation, and startup activities.
- Clear career growth opportunities and competitive compensation/benefits.
- Professional development and training in regulated manufacturing environments.
Location & Employment Type
- Location: Indianapolis, IN (on-site/project locations in the Indianapolis area)
- Employment Type: Full-time
- Level: Hiring at C&Q Engineer I (entry) and C&Q Engineer II (experienced) based on qualifications.
Notes on Hiring & Compliance
Careertakes and our client follow all applicable federal, state, and local employment laws. Applicants will not be asked for information that violates anti-discrimination statutes. Reasonable accommodations are available for applicants with disabilities during the hiring process — please indicate any accommodation needs.
Equal Opportunity & Hiring Transparency
Careertakes and our client are Equal Opportunity Employers committed to building a diverse and inclusive workforce. We prohibit discrimination or harassment of any kind. To support a fair and efficient hiring process, AI tools may be used to assist with application review or resume screening. These tools do not replace human decision-making. Final hiring decisions are made by people.
If you have questions about how your data is used, please contact us directly.
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