CQV Engineer

EFOR

Basel

On-site

CHF 110,000 - 140,000

Full time

9 hours ago
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Job summary

EFOR Group in Switzerland seeks a CQV Engineer to support pharma/biotech projects. You will oversee commissioning, qualification and validation for GMP facilities, equipment, utilities and laboratory systems, collaborating with Engineering, Quality, Manufacturing, Automation and vendors.

The on-site role requires a degree in Engineering or life sciences, CQV experience with IQ/OQ/PQ, and GMP lifecycle knowledge. Fluent English is required; German is an advantage.

Qualifications

  • Experience in CQV, Qualification, Validation within a regulated environment.
  • Knowledge of GMP requirements and validation lifecycle.
  • Experience with IQ, OQ, and PQ protocol execution.
  • Strong problem-solving and organizational skills.
  • Excellent communication and teamwork; fluent English; German a plus.

Responsibilities

  • Plan, execute, and document qualification activities for GMP systems.
  • Develop, review, and execute IQ/OQ/PQ protocols.
  • Support FAT and SAT activities.
  • Collaborate with cross-functional teams and external vendors.
  • Ensure GMP compliance and participate in audits.
  • Identify opportunities for process improvements.

Skills

CQV
IQ/OQ/PQ
GMP knowledge
Documentation & Compliance

Education

Bachelor's or Master's degree in Engineering/ Biotechnology/ Pharmaceutical Sciences

Job description

In 13 years, the EFOR Group has reached the leading position in Life Sciences consulting with strong, synergic and strategic acquisitions.

Our ambition is to build a global leading position of our market in 2028.

Today, we are an innovative organization working with passionate specialists and committed consultants according to our three values: Commitment, Excellence and Sharing.

In Switzerland, we work with 300 experts who support our customers on their various projects in the French- and German-speaking parts. We help our customers to diversify and to grow through the work of our consultants and the technical expertise of our Solution & Project Delivery Department.

About the Role

We are looking for a motivated CQV Engineer (Commissioning, Qualification & Validation) to support projects within the pharmaceutical, biotechnology, and life sciences industries.

In this role, you will be responsible for the commissioning, qualification, and validation of GMP facilities, manufacturing equipment, utilities, and laboratory systems. You will work closely with Engineering, Quality, Manufacturing, Automation, and external vendors to ensure compliance with regulatory and quality requirements.

Key Responsibilities
  • Plan, execute, and document commissioning, qualification, and validation activities for GMP systems and equipment
  • Develop, review, and execute qualification protocols, including IQ, OQ, and PQ
  • Support FAT (Factory Acceptance Testing) and SAT (Site Acceptance Testing) activities
  • Perform risk assessments and ensure proper GMP documentation
  • Support deviation investigations, CAPAs, and change control activities
  • Collaborate with cross-functional teams, suppliers, and project stakeholders
  • Ensure compliance with GMP regulations, industry standards, and internal procedures
  • Review technical documentation such as URS, design specifications, and vendor documentation
  • Participate in audits and regulatory inspections
  • Identify opportunities for process improvements and continuous optimization
Qualifications
  • Bachelor's or Master's degree in Engineering, Biotechnology, Pharmaceutical Sciences, Chemistry, or a related discipline
  • Experience in CQV, Qualification, Validation, or GMP Engineering within a regulated environment
  • Knowledge of GMP requirements and validation lifecycle principles
  • Experience with IQ, OQ, and PQ protocol execution
  • Strong problem-solving and organizational skills
  • Excellent communication and teamwork abilities
  • Fluent English required; German is considered a strong advantage

This is an on-site role.

Only applicants with Swiss or EU/EFTA citizenship or candidates with an existing and valid residence and work permit in Switzerland will be considered.

Do you want to join a dynamic and ambitious company? EFOR is made for you.

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