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.

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