No deviation

Senior C&Q Engineer

No deviation  •  Bohumín, CZ (Onsite)  •  2 months ago
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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.

We are seeking a Senior C&Q Engineer to lead commissioning and qualification activities across various systems, ensuring compliance with industry standards. This role involves overseeing the full project lifecycle, from protocol generation to system handover. Ideal candidates will have at least 5 years of experience in the pharmaceutical industry, strong technical knowledge, and a proactive, solution-driven attitude.

Key Responsibilities

  • Oversee the commissioning of systems and equipment to ensure they meet specified requirements and are operationally ready.
  • Develop and maintain comprehensive qualification documentation, conduct testing protocols (IQ, OQ, PQ) to validate that systems function according to specification, and to ensure that all systems are fully operational and meet required specifications.
  • Ensure all C&Q activities comply with regulatory guidelines and industry standards.
  • Work closely with all other WPOs as well as local site engineering, operations, maintenance, and quality assurance teams to ensure seamless integration and adherence to project timelines.
  • Follow commissioning strategy developed by C&Q WPO.
  • Review and approve all qualification documentation, ensuring comprehensiveness and compliance.

Required Qualifications

  • Bachelors or Masters degree in Pharma Technology, Process Engineering, Biotechnology, or related field.
  • At least 5 years of experience in Pharmaceutical industry, preferably within any related production area.
  • In-depth technical knowledge in the assigned area and associated regulatory requirements, guidelines, and other industry best practices.
  • Ability to work in a fast paced & dynamic work environment.
  • Strong knowledge of GMP, and qualification lifecycle documentation.
  • Proven success in project management tools and methodologies.
  • Exceptional communication, negotiation, and leadership skills.

Why join us?

  • 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.

No deviation

About No deviation

Founded in 2007, No deviation is a trusted partner to pharmaceutical and biotech companies seeking smarter ways to deliver compliance. From engineering consultancy to CQV execution, regulatory compliance, and digital enablement, we support our clients across the entire project lifecycle in Asia, Europe.

We specialise in:

CQV (Commissioning, Qualification & Validation)

Lean, risk-based approaches aligned with GAMP 5, Annex 15, and ASTM E2500.

Quality, Compliance & Regulatory

Audit readiness, QMS remediation, documentation, and training.

Project Management & Technical Support

From operational readiness to vendor coordination.

Digital Enablement

Implementation of paperless validation (e.g. Kneat Gx), data integrity, and process digitalisation.

Specialised Training & Talent Support

Upskilling programs and resource placement to accelerate project success.

Our approach is rooted in patient safety, process understanding, regulatory compliance, and a constant drive for operational excellence in terms of safety, quality, delivery, and cost.

If you’re troubleshooting a deviation, planning a major CQV deployment, or scaling digital validation tools, we work side-by-side with your teams to deliver meaningful outcomes. Our methodology draws from ICHQ9 risk principles, with a hands-on framework: Understand - Observe - Define - Implement.

Want to learn more about paperless CQV, digital QMS, or project-ready resources? We’re happy to talk. Visit nodeviation.com to explore how we can support you.

Industry
Chemicals & Materials
Company Size
51-200 employees
Headquarters
Singapore, SG
Year Founded
2007
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