At a Glance
- Tasks: Oversee CQV activities and ensure compliance in exciting capital projects.
- Company: Leading pharmaceutical company focused on innovation and quality.
- Benefits: Competitive salary, health benefits, and opportunities for professional growth.
- Other info: Join a dynamic team with a commitment to excellence and compliance.
- Why this job: Make a real impact in the pharmaceutical industry while ensuring product quality.
- Qualifications: Bachelor's degree in Engineering and 5 years of CQV experience required.
The predicted salary is between 92475 - 113025 $ per year.
Overview Our Client is seeking a Process Engineer to support capital projects on site, providing technical oversight of Commissioning, Qualification and Validation (CQV) activities.
The successful candidate will ensure process requirements, GMP principles and risk-based methodologies are appropriately applied throughout project delivery, maintaining compliance and inspection readiness.
Key Responsibilities
Provide technical oversight and review of CQV documentation, including commissioning plans, risk assessments, qualification protocols and reports.
Ensure process requirements are effectively translated into GMP-compliant design and qualification strategies.
Support the identification, justification and control of critical quality attributes (CQAs) and critical process parameters (CPPs).
Apply risk-based approaches to determine qualification scope, testing requirements and verification activities.
Review and approve CQV strategies, plans and lifecycle documentation.
Challenge and guide project teams, vendors and CQV service providers to ensure regulatory and industry best practice compliance.
Support design reviews, change controls and deviation investigations from a technical compliance perspective.
Ensure systems remain in a validated state and support ongoing inspection readiness.
Requirements
Bachelor's degree in Engineering (Chemical, Mechanical, Electrical or related discipline).
Minimum 5 years' experience in Commissioning, Qualification and Validation (CQV) within a regulated pharmaceutical environment.
Strong understanding of pharmaceutical manufacturing processes, CQAs and CPPs.
Working knowledge of GMP regulations and industry standards, including EU GMP, FDA and ICH guidelines.
Experience reviewing and approving CQV lifecycle documentation.
Strong risk assessment, problem-solving and analytical skills.
Excellent stakeholder management and communication abilities.
Ability to identify, assess and escalation compliance and quality risks.
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Process Engineer employer: DPS Group Global
Join a forward-thinking company that prioritizes innovation and sustainability in wastewater treatment solutions. With a strong emphasis on collaboration and safety, employees are encouraged to grow professionally through mentorship opportunities and hands-on project involvement. Located in a vibrant community, this role offers a unique chance to make a meaningful impact while working alongside passionate professionals dedicated to excellence.
