Job Description

About No deviation

At No deviation, we are dedicated to delivering patient-centric solutions that revolutionize the pharmaceutical landscape. As a dynamic expert in engineering consultancy, Commissioning Qualification Validation (CQV), and Quality, Compliance, and Regulatory services, we are looking for individuals who are excited to contribute to impactful projects and drive innovation.

We believe that great things happen when Empathy, Integrity, and Transparency guide our actions. That's why we foster a culture of collaboration, inclusion, and continuous development – empowering our team members to grow personally and professionally.

The CQV Engineer is responsible to support commissioning, qualification and validation activities for GMP process equipment and utilities in a pharmaceutical / biotechnology environment. Focus on equipment such as stainless steel vessels, CIP/SIP systems, thermal systems and related process utilities Prepare, execute, review and close CQV documentation in line with GMP, GDP and project requirements.

Key Responsibilities

• Prepare and execute CQV documents, including: Commissioning protocols, IQ / OQ / PQ protocols, Test scripts, Qualification reports, Deviation reports, Traceability matrices
• Support qualification of stainless steel vessels, including: Mixing vessels, Holding tanks, Buffer / media preparation vessels, Process tanks, Product-contact equipment
• Perform Material of Construction checks for stainless steel equipment, including verification of: MOC certificates, Surface finish, Welding documentation, Passivation records, Product-contact parts, Gasket / seal materials
  
• Support CIP and SIP qualification, including: Cycle verification, Sprayball coverage checks, Flow / pressure / temperature verification, Conductivity checks, Hold time verification, Drainability checks, Sterilisation cycle assessment
• Support thermal mapping / temperature qualification activities for GMP equipment and systems.
• Execute qualification testing and document results in accordance with approved protocols.
• Use Kneat for protocol execution, review, comment resolution and document lifecycle management.
• Support FAT / SAT, commissioning walkdowns and system handover activities.
• Review vendor documents, drawings, P&IDs, datasheets, manuals and calibration records.
• Raise and support closure of deviations, punch items, non-conformities and qualification discrepancies.
• Work with QA, Engineering, Manufacturing, Automation, Vendors and Project teams to ensure timely CQV completion.
• Ensure all qualification activities comply with GMP, GDP, data integrity and site SOP requirements.

Required Qualifications

• Degree / Diploma in Engineering, Biotechnology, Pharmaceutical Science, Life Sciences or related discipline.
• 3 to 5 years of relevant CQV experience in pharmaceutical, biotech, biologics or GMP manufacturing environment.
• Hands-on experience with CIP, SIP, thermal mapping and stainless steel process equipment
• Experience performing Material of Construction checks for GMP equipment.
• Familiar with IQ / OQ / PQ execution and GMP documentation requirements.
• Experience using Kneat for validation document execution and review.
• Able to read and understand P&IDs, equipment drawings, datasheets and vendor technical documents.
• Good understanding of GMP, GDP, deviation management and change control.
• Strong documentation discipline and attention to detail.
• Able to work independently on site and coordinate with cross-functional teams.

Why join us?

• Generous Leave Policy.
• Comprehensive Health & Wellness Coverage: Receive robust medical and dental coverage to support your health needs.
• Professional Development Opportunities: Access continuous learning programs and resources for career growth within the company.
• Inclusive Culture: Work in an environment where innovation, collaboration, and diverse perspectives are encouraged and celebrated.
• Shape the Future: Make a real difference in the pharmaceutical industry while advancing your career.

How to apply

Are you ready to play a key role in shaping the future of pharmaceutical solutions? If you're passionate about making an impact, we want you on our team!

Please submit your resume, outlining your qualifications and experience relevant to the role, here.