What are the responsibilities and job description for the Commissioning & Qualification/CQV Engineer position at Compleat Technical Solutions Inc?
Role: Commissioning & Qualification/CQV Engineer
Location: Boston, MA. *Fully onsite
Duration: 12 months
Only W2, No C2C
Job Description
The right candidate will be a detail-oriented and proactive CQ Project Engineer to support the execution of commissioning and qualification activities for equipment and systems in our API manufacturing facility. This role is ideal for candidates with technical expertise and a working knowledge of facility, utilities and API manufacturing process systems who excel in documentation, data analysis, and cross-functional coordination.
Must Haves:
- Engineering degree. ChemE or Mechanical Engineering will be strongly preferred
- 5-7 years’ experience with commissioning and qualification (this is not a validation engineer position)
- Needs to be familiar with piping design and instrumentation
- Pharmaceutical/Biotechnology background
- Knowledge of regulatory requirements and industry standards for commissioning and qualification
- Highly flexible and capable of managing multiple priorities simultaneously while meeting tight deadlines
Roles and Responsibilities:
- Report directly to the C&Q Node Lead, providing updates on the progress, risks, and issues related to C&Q activities.
- Maintain and update C&Q trackers, schedules, and status dashboards to support project visibility and decision-making.
- Review and interpret engineering drawings, specifications, and technical documents.
- Track procurement progress and equipment arrivals, equipment installations, system MCs, etc. with cross-functional teams (eg: Construction teams, Engineering, C&Q Service Providers, Operations, etc.).
- Participate in C&Q execution readiness.
- Coordinate and assist with HSE related activities such as Permit to Work, Job Hazard Analyses, Safety Walks, etc.
- Coordinate with cross-functional teams (eg: QA, Engineering, C&Q Service Providers, Operations, etc.) for C&Q activities.
- Actively track field progress and engage in C&Q field activities (eg: perform walkdowns of systems, equipment, and infrastructure. Ensure alignment with design specifications, HSE, and C&Q operational standards, etc.).
- Participate in meetings, take minutes, and follow up on action items related to C&Q activities.
- Ensure all documentation is maintained in accordance with GMP and internal quality standards.
- Any tasks assigned by the C&Q Program.