Validation Engineer

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.

Position Overview

We are looking for a Validation Engineer to support qualification and validation activities within a GMP pharmaceutical/biopharmaceutical manufacturing environment. The role will be responsible for planning, executing, documenting, and supporting validation activities for equipment, systems, utilities, and manufacturing processes.

Key Responsibilities

• Develop, review, and execute validation and qualification documentation, including:
  • Validation Plans / Qualification Plans
  • URS
  • Risk Assessments
  • IQ/OQ/PQ protocols
  • Validation protocols and reports
  • Traceability matrices
  • Qualification Summary Reports
• Perform qualification and validation activities for:
  • Manufacturing equipment
  • Process equipment
  • Clean utilities
  • Laboratory equipment
  • Facility and support systems
• Support commissioning and qualification activities for new equipment and facility projects.
• Coordinate and execute IQ, OQ and PQ testing in accordance with approved protocols and project schedules.
• Review test results, identify discrepancies, and ensure appropriate documentation and resolution of deviations.
• Initiate and support deviation investigations, CAPA and change control activities related to validation.
• Ensure validation activities comply with GMP requirements, site procedures and applicable regulatory expectations.
• Maintain accurate and contemporaneous validation documentation in accordance with Data Integrity / ALCOA+ principles.
• Support equipment modification, requalification and periodic review activities.
• Participate in risk assessments and define appropriate validation strategies based on system criticality and intended use.
• Work closely with Engineering, Manufacturing, QA, QC, MSAT, Automation and vendors to coordinate validation activities.
• Support regulatory inspections and internal/external audits where required.
• Track validation activities and ensure deliverables are completed according to agreed project timelines.

Required Qualifications

• Diploma or Degree in Engineering, Pharmaceutical Sciences, Biotechnology, Life Sciences or a related discipline.
• Relevant experience in validation, qualification, CQV, engineering or pharmaceutical manufacturing.
• Good understanding of GMP and equipment/system qualification principles.
• Experience preparing and executing IQ/OQ/PQ protocols is preferred.
• Familiarity with deviation, CAPA, change control and risk assessment processes.
• Experience with pharmaceutical manufacturing equipment, utilities or laboratory systems would be advantageous.
• Knowledge of regulatory expectations such as EU GMP, FDA requirements, GAMP 5 or ASTM E2500 would be an advantage.
• Good technical writing, documentation, troubleshooting and communication skills.
• Able to work independently and collaborate effectively 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.